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510(k) K000528

ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 by Sigma Diagnostics, Inc. — Product Code GIR

K000528 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119". The FDA issued a decision of Substantially Equivalent on Apr 7, 2000. The device falls under product code GIR (Reagent, Russel Viper Venom), a Class I device regulated under 21 CFR 864.8950. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 7, 2000
Date Received
Feb 17, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Reagent, Russel Viper Venom
Device Class
Class I
Regulation Number
864.8950
Review Panel
HE
Submission Type
510(k)

Other clearances by Sigma Diagnostics, Inc.

  • K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX… (Aug 30, 2002)
  • K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (Feb 6, 2002)
  • K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (Dec 26, 2001)
  • K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (Nov 15, 2001)
  • K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (Nov 15, 2001)
  • K012410 — INFINITY HBA KIT, MODELS 537-A, 537-B (Oct 26, 2001)
  • K010652 — SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (Mar 30, 2001)
  • K010158 — THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (Mar 22, 2001)
  • K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (Mar 15, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (Mar 1, 2001)

Other clearances for product code GIR

  • K132130 — REAGENT, RUSSEL VIPER VENOM - LA SCREEN (Jan 10, 2014)
  • K132076 — REAGENT, RUSSEL VIPER VENOM - LA CONFIRM (Jan 10, 2014)
  • K110031 — HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM (Aug 24, 2011)
  • K083878 — LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA (Jun 25, 2010)
  • K061805 — STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM (Dec 6, 2006)
  • K000527 — ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 (Apr 7, 2000)
  • K990580 — CRYOCHECK LA SURE, MODEL SUR25-10 (Jul 28, 1999)
  • K990579 — CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) (Jul 23, 1999)
  • K990302 — IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS… (Apr 8, 1999)
  • K940490 — DV TEST AND DVV CONFIRM (Apr 5, 1995)

FDA data resources

Source: FDA 510(k) database entry for K000528. Report a data issue: hello@regdatalab.com.