Sigma Diagnostics, Inc.: 510(k) Clearances
164 510(k) clearances from Jun 14, 1984 to Aug 30, 2002, newest first. Showing 101 to 164.
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-Number | Device | Date |
|---|
| K894063 | TRIGLYCERIDE (GPO) TRINDER REAGENT | Sep 7, 1989 |
| K884184 | SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE | Mar 28, 1989 |
| K890674 | ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET | Feb 24, 1989 |
| K890673 | WRIGHT-GLEMSA STAIN | Feb 24, 1989 |
| K890023 | HDL CHOLESTEROL REAGENT (PTA/MGCL2) | Feb 17, 1989 |
| K881112 | FUNGI HISTOLOGY CONTROL SLIDES | Apr 21, 1988 |
| K881109 | SPIROCHETES HISTOLOGY CONTROL SLIDES | Apr 21, 1988 |
| K881106 | ACID FAST BACILLI HISTOLOGY CONTROL SLIDES | Apr 21, 1988 |
| K880038 | FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 | Apr 21, 1988 |
| K881110 | LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES | Apr 12, 1988 |
| K881108 | PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES | Apr 12, 1988 |
| K881111 | INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL | Mar 30, 1988 |
| K881107 | INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES | Mar 30, 1988 |
| K880268 | CO2 REAGENT | Mar 15, 1988 |
| K880039 | AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665 | Feb 24, 1988 |
| K875310 | RETICULOCYTE STAIN | Feb 9, 1988 |
| K874115 | NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA) | Nov 4, 1987 |
| K873342 | BILE ACIDS CONTROLS | Oct 20, 1987 |
| K873365 | CREATININE REAGENT | Oct 2, 1987 |
| K872296 | BILE ACIDS REAGENT | Aug 26, 1987 |
| K872451 | BILE ACIDS CALIBRATOR | Aug 21, 1987 |
| K872197 | PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT | Aug 13, 1987 |
| K872295 | CHOLESTEROL REAGENT | Jul 16, 1987 |
| K872347 | DIGOXIN FPIA CONTROLS | Jul 7, 1987 |
| K871567 | PHENYTOIN FPIA CONTROLS | Jul 1, 1987 |
| K871152 | SIGMA'S CALCIUM PROCEDURE NO. 587 | Jun 12, 1987 |
| K871423 | PHENYTOIN FPIA CALIBRATORS | Jun 11, 1987 |
| K871394 | THEOPHYLLINE FPIA CALIBRATORS | Jun 1, 1987 |
| K871545 | NEW FUCHSIN SOLUTION | Apr 29, 1987 |
| K871544 | METHYL GREEN SOLUTION | Apr 29, 1987 |
| K870951 | DIGOXIN FPIA REAGENT SET | Apr 1, 1987 |
| K870953 | PHENYTOIN FPIA REAGENT SET | Mar 31, 1987 |
| K870952 | THEOPHYLLINE FPIA REAGENT SET | Mar 31, 1987 |
| K870012 | TRIGLYCERIDE (GPO-TRINDER) REAGENT | Feb 20, 1987 |
| K864713 | CHLORIDE REAGENT | Dec 31, 1986 |
| K864531 | TISSUE GRAM STAIN | Dec 22, 1986 |
| K863751 | MULTI-ANALYTE LIN-TROL | Nov 24, 1986 |
| K864033 | RAPID ACID FAST STAIN | Nov 13, 1986 |
| K864074 | ELASTIC STAIN | Oct 29, 1986 |
| K863851 | ACID PHOSPHATASE (ACP) REAGENT | Oct 16, 1986 |
| K863226 | ALBUMIN (BCP) | Sep 17, 1986 |
| K863203 | CHOLINESTERASE (BTC) REAGENT | Sep 17, 1986 |
| K863202 | CHOLINESTERASE (PTC) REAGENT | Sep 16, 1986 |
| K862905 | ALP (OPT) REAGENT | Aug 29, 1986 |
| K863196 | BUN (RATE) REAGENT | Aug 26, 1986 |
| K861314 | CHOLESTEROL CALIBRATORS | Jul 1, 1986 |
| K861467 | ALBUMIN (BCG) REAGENT | May 23, 1986 |
| K860138 | NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM | Mar 28, 1986 |
| K860453 | ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040 | Feb 19, 1986 |
| K854245 | SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV | Jan 22, 1986 |
| K854501 | CK(OPTIMIZED) REAGENT | Dec 4, 1985 |
| K854503 | AST(OPTIMIZED) REAGENT | Nov 25, 1985 |
| K854502 | ALT(OPTIMIZED) REAGENT | Nov 25, 1985 |
| K853681 | SIGMA 610 FOR PROTEIN IN URINE & CSF | Oct 28, 1985 |
| K853896 | GRAM STAIN KIT | Oct 22, 1985 |
| K853357 | URIC ACID REAGENT | Aug 19, 1985 |
| K852131 | BUN(ENDPOINT) REAGENT | Jun 10, 1985 |
| K852130 | GLUCOSE(TRINDER) REAGENT | Jun 10, 1985 |
| K850923 | BUN (RATE) REAGENT | Mar 20, 1985 |
| K850319 | Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT | Feb 12, 1985 |
| K844468 | TRIGLYCERIDE CALIBRATOR | Dec 11, 1984 |
| K844032 | TRIGLYCERIDE REAGENT | Nov 9, 1984 |
| K841918 | SIGMA PROCED. 245 ALKALINE PHOSPHATASE | Jun 14, 1984 |
| K841917 | SIGMS PROCED. 228 UV LACTATE DEHYDRO | Jun 14, 1984 |