Home / Companies / Sigma Diagnostics, Inc. / 510(k) Clearances

Sigma Diagnostics, Inc.: 510(k) Clearances

164 510(k) clearances from Jun 14, 1984 to Aug 30, 2002, newest first. Showing 1 to 100.

What this list covers: FDA records filed under the name "Sigma Diagnostics, Inc." and its spelling variant "Sigma Diagnostics".

Back to the Sigma Diagnostics, Inc. profile

K-NumberDeviceDate
K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION…Aug 30, 2002
K020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLFeb 6, 2002
K013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971Dec 26, 2001
K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221Nov 15, 2001
K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096Nov 15, 2001
K012410INFINITY HBA KIT, MODELS 537-A, 537-BOct 26, 2001
K010652SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936Mar 30, 2001
K010158THROMBOMAX-HS WITH CALCIUM, MODEL T6540Mar 22, 2001
K003267SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-AMar 15, 2001
K003329SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217Mar 1, 2001
K003328ACCUCLOT CONTROL I, MODEL A4089Mar 1, 2001
K001403SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100PAug 10, 2000
K993741EZ LDL CHOLESTEROL TEST SYSTEMJul 3, 2000
K001569INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)Jun 26, 2000
K000528ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119Apr 7, 2000
K000527ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094Apr 7, 2000
K992712SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334Dec 6, 1999
K992711SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094Dec 6, 1999
K992801SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT…Sep 28, 1999
K992800SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100PSep 28, 1999
K992798SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20…Sep 28, 1999
K992803SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P…Sep 13, 1999
K984574INFINITY GLUCOSE REAGENTFeb 11, 1999
K982209ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589Oct 15, 1998
K982251SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KITAug 18, 1998
K982236SIGMA DIAGNOSTICS INFINITY BUN REAGENT KITAug 5, 1998
K981255SIGMA DIAGNOSTICS ACCUCLOT CONTROL IIIApr 29, 1998
K981254SIGMA DIAGNOSTICS ACCUCLOT CONTROL IIApr 29, 1998
K981248SIGMA DIAGNOSTICS ACCUCLOT CONTROL IApr 29, 1998
K980667INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)Apr 21, 1998
K980666INFINITY AST REAGENT (PROCEDURE NO. 51)Mar 20, 1998
K973274ACCUCOLOR HIGH CALIBRATOR (A3089)Oct 31, 1997
K972260CS-400 COAGULATION ANALYZER SYSTEM (A1208)Oct 20, 1997
K972796SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUMOct 10, 1997
K971858SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)Oct 9, 1997
K972743SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENTSep 22, 1997
K972794DIGOXIN DG-II FPIA REAGENT SETJul 31, 1997
K972132SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORSJul 30, 1997
K972144SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN IIIJul 25, 1997
K972041EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)Jul 22, 1997
K963535SIGMA DIAGNOSTICS GLUCOSE REAGENTJan 17, 1997
K963539SIGMA DIAGNOSTICS WASH CONCENTRATEDec 16, 1996
K963543SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2Oct 30, 1996
K963533SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1Oct 29, 1996
K963541SIGMA DIAGNOSTICS CO2 ACID REAGENTOct 24, 1996
K963537SIGMA DIAGNOSTICS BUN REAGENTOct 24, 1996
K963538SIGMA DIAGNOSTICS CO2ALKALINE BUFFEROct 11, 1996
K963536SIGMA DIAGNOSTICS CALICIUM REAGENTOct 10, 1996
K963534SIGMA DIAGNOSTICS CREATININE REAGENT KITSep 30, 1996
K963542SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENTSep 27, 1996
K963540SIGMA DIAGNOSTICS ELECTROLYTE BUFFERSep 27, 1996
K960875KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)Sep 10, 1996
K955720AMAX CS-190 COAGULATION ANALYZER SYSTEMMar 13, 1996
K955724KC 1A COAGULATION ANALYZER/SETMar 12, 1996
K955735KC 4A MICRO COAGULATION ANALYZER SET/SYSTEMMar 11, 1996
K954840ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245Feb 28, 1996
K955716VANCOMYCIN FPIA REAGENT SETFeb 16, 1996
K952557TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORSJan 24, 1996
K954839ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UVJan 5, 1996
K951584ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247Aug 11, 1995
K933934GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-AJun 29, 1995
K945908GLUCOSE (HK) REAGENT (PROCEDURE NO.16)May 8, 1995
K950028PRIMIDONE FPIA REAGENT SET AND CALIBRATORSMar 21, 1995
K942908IGM RF EIAJan 20, 1995
K943291ANTI DS-DNADec 2, 1994
K943550GENTAMICIN FPIA REAGENT SET AND CALIBRATORSNov 17, 1994
K944371TOBRAMYCIN FPIA REAGENT SET AND CALIBRATORNov 10, 1994
K944063FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINENov 10, 1994
K943866VALPROIC ACID FPIA REAGENT SET AND CALIBRATORSNov 10, 1994
K943313PHENYTOIN FPIA REAGENT SET AND CALIBRATORSOct 27, 1994
K935984GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419Jul 20, 1994
K940840ACT CONTROL SETJul 19, 1994
K942192THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORSJul 13, 1994
K940569DIGOXIN FPIA REAGENT SET AND CALIBRATOR SETJul 13, 1994
K932606APOLIPOPROTIEN A-1 (APO A-1)Jun 2, 1994
K932603APOLIPOPROTIEN B (APO B)Jun 2, 1994
K941085LIPASE-PS ASSAY PROCEDURE NO. 805May 17, 1994
K935308ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAYMay 17, 1994
K935057FACTOR VIII DEFICIENT PLASMAMar 15, 1994
K935058FACTORMar 7, 1994
K935056FACTOR VII DEFICIENT PLASMAMar 7, 1994
K935054FACTOR X DEFICIENT PLASMAMar 7, 1994
K933425AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812Nov 16, 1993
K932517IRON/UIBC REAGENTNov 9, 1993
K932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Oct 18, 1993
K932067ETHANOL CONTROLS, URINE, LEVELS 1,II, AND IIIJun 16, 1993
K930212THROMBOPLATIN-M WITH CALCIUMMay 11, 1993
K915462FIBRINOGEN CONTROLMar 4, 1992
K915380MICROPROTEIN-PRFeb 18, 1992
K915465DIGITOXIN FPIA REAGENT SETJan 27, 1992
K915463ACTIVATED PARTIAL THROMBOPLASTIN TIMEJan 23, 1992
K915464DIGITOXIN FPIA CALIBRATOR SETJan 15, 1992
K914777SIGMA PROCEDURE NO. 333-UVDec 27, 1991
K913061FIBRINOGEN DETERMINATION KITOct 9, 1991
K913858AMYLASE REAGENT (PROCEDURE 577)Sep 11, 1991
K912061HEPARIN ADSORBENTJul 24, 1991
K910741HEPARIN CONTROLS, HIGH AND LOWApr 29, 1991
K910255FLOW CYTOMETRY FITC/PE COMPENSATION KITApr 3, 1991
K897147SIGMA PROCEDURE NO. 735Apr 3, 1990
K894204CALCIUM (ARSENAZO III) REAGENTOct 4, 1989

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.