Company ยท US
Sigma Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2002. Name variants (Inc, Corp, punctuation) are merged.
164510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 8 |
| LJG | Quality Control Slides | 7 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 5 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 4 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 4 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 4 |
| GJT | Plasma, Coagulation Factor Deficient | 4 |
| CFR | Hexokinase, Glucose | 3 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 3 |
| DLJ | Calibrators, Drug Specific | 3 |
| GGN | Plasma, Coagulation Control | 3 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 3 |
| JIT | Calibrator, Secondary | 3 |
| JIX | Calibrator, Multi-Analyte Mixture | 3 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 3 |
| KXT | Enzyme Immunoassay, Digoxin | 3 |
| CDO | Acid, Uric, Uricase (U.V.) | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 30, 2002 | K021162 | AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED Sigma Diagnostics, Inc. | JPA |
| Feb 6, 2002 | K020109 | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL Sigma Diagnostics, Inc. | GGC |
| Dec 26, 2001 | K013549 | SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 Sigma Diagnostics, Inc. | DAP |
| Nov 15, 2001 | K013545 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 Sigma Diagnostics, Inc. | DAP |
| Nov 15, 2001 | K013544 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 Sigma Diagnostics, Inc. | DAP |
| Oct 26, 2001 | K012410 | INFINITY HBA KIT, MODELS 537-A, 537-B Sigma Diagnostics, Inc. | LCP |
| Mar 30, 2001 | K010652 | SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 Sigma Diagnostics, Inc. | JIX |
| Mar 22, 2001 | K010158 | THROMBOMAX-HS WITH CALCIUM, MODEL T6540 Sigma Diagnostics, Inc. | GGO |
| Mar 15, 2001 | K003267 | SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A Sigma Diagnostics, Inc. | DAP |
| Mar 1, 2001 | K003329 | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 Sigma Diagnostics, Inc. | GGC |
| Mar 1, 2001 | K003328 | ACCUCLOT CONTROL I, MODEL A4089 Sigma Diagnostics, Inc. | GIZ |
| Aug 10, 2000 | K001403 | SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P Sigma Diagnostics, Inc. | CFR |
| Jul 3, 2000 | K993741 | EZ LDL CHOLESTEROL TEST SYSTEM Sigma Diagnostics, Inc. | MRR |
| Jun 26, 2000 | K001569 | INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) Sigma Diagnostics, Inc. | JFJ |
| Apr 7, 2000 | K000528 | ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 Sigma Diagnostics, Inc. | GIR |
| Apr 7, 2000 | K000527 | ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 Sigma Diagnostics, Inc. | GIR |
| Dec 6, 1999 | K992712 | SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 Sigma Diagnostics, Inc. | GFO |
| Dec 6, 1999 | K992711 | SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 Sigma Diagnostics, Inc. | GFO |
| Sep 28, 1999 | K992801 | SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 Sigma Diagnostics, Inc. | CIT |
| Sep 28, 1999 | K992800 | SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P Sigma Diagnostics, Inc. | CDQ |
| Sep 28, 1999 | K992798 | SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P Sigma Diagnostics, Inc. | CDO |
| Sep 13, 1999 | K992803 | SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP Sigma Diagnostics, Inc. | CHH |
| Feb 11, 1999 | K984574 | INFINITY GLUCOSE REAGENT Sigma Diagnostics, Inc. | CFR |
| Oct 15, 1998 | K982209 | ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 Sigma Diagnostics, Inc. | GJA |
| Aug 18, 1998 | K982251 | SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT Sigma Diagnostics, Inc. | CDO |
| Aug 5, 1998 | K982236 | SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT Sigma Diagnostics, Inc. | CDQ |
| Apr 29, 1998 | K981255 | SIGMA DIAGNOSTICS ACCUCLOT CONTROL III Sigma Diagnostics, Inc. | GGN |
| Apr 29, 1998 | K981254 | SIGMA DIAGNOSTICS ACCUCLOT CONTROL II Sigma Diagnostics, Inc. | GGN |
| Apr 29, 1998 | K981248 | SIGMA DIAGNOSTICS ACCUCLOT CONTROL I Sigma Diagnostics, Inc. | GGN |
| Apr 21, 1998 | K980667 | INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) Sigma Diagnostics, Inc. | CHH |
| Mar 20, 1998 | K980666 | INFINITY AST REAGENT (PROCEDURE NO. 51) Sigma Diagnostics, Inc. | CIT |
| Oct 31, 1997 | K973274 | ACCUCOLOR HIGH CALIBRATOR (A3089) Sigma Diagnostics, Inc. | GIZ |
| Oct 20, 1997 | K972260 | CS-400 COAGULATION ANALYZER SYSTEM (A1208) Sigma Diagnostics, Inc. | JPA |
| Oct 10, 1997 | K972796 | SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM Sigma Diagnostics, Inc. | GJS |
| Oct 9, 1997 | K971858 | SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) Sigma Diagnostics, Inc. | KQJ |
| Sep 22, 1997 | K972743 | SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT Sigma Diagnostics, Inc. | CGX |
| Jul 31, 1997 | K972794 | DIGOXIN DG-II FPIA REAGENT SET Sigma Diagnostics, Inc. | KXT |
| Jul 30, 1997 | K972132 | SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS Sigma Diagnostics, Inc. | LEG |
| Jul 25, 1997 | K972144 | SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III Sigma Diagnostics, Inc. | JBQ |
| Jul 22, 1997 | K972041 | EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) Sigma Diagnostics, Inc. | LBS |
| Jan 17, 1997 | K963535 | SIGMA DIAGNOSTICS GLUCOSE REAGENT Sigma Diagnostics, Inc. | CGA |
| Dec 16, 1996 | K963539 | SIGMA DIAGNOSTICS WASH CONCENTRATE Sigma Diagnostics, Inc. | JJE |
| Oct 30, 1996 | K963543 | SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2 Sigma Diagnostics, Inc. | JIX |
| Oct 29, 1996 | K963533 | SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1 Sigma Diagnostics, Inc. | JIX |
| Oct 24, 1996 | K963541 | SIGMA DIAGNOSTICS CO2 ACID REAGENT Sigma Diagnostics, Inc. | JFL |
| Oct 24, 1996 | K963537 | SIGMA DIAGNOSTICS BUN REAGENT Sigma Diagnostics, Inc. | LFP |
| Oct 11, 1996 | K963538 | SIGMA DIAGNOSTICS CO2ALKALINE BUFFER Sigma Diagnostics, Inc. | JFL |
| Oct 10, 1996 | K963536 | SIGMA DIAGNOSTICS CALICIUM REAGENT Sigma Diagnostics, Inc. | CJY |
| Sep 30, 1996 | K963534 | SIGMA DIAGNOSTICS CREATININE REAGENT KIT Sigma Diagnostics, Inc. | CGX |
| Sep 27, 1996 | K963542 | SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT Sigma Diagnostics, Inc. | JGS |
Newest 50 of 164.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||