Company ยท US
Sigma Chemical Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1994. Name variants (Inc, Corp, punctuation) are merged.
231510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 87 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 9 |
| GJT | Plasma, Coagulation Factor Deficient | 8 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 4 |
| GKZ | Counter, Differential Cell | 4 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 4 |
| KIP | Formulations, Balanced Salt Solutions | 4 |
| GGN | Plasma, Coagulation Control | 3 |
| GHD | Test, Leukocyte Alkaline Phosphatase | 3 |
| HYB | Eosin Y | 3 |
| JIX | Calibrator, Multi-Analyte Mixture | 3 |
| CFR | Hexokinase, Glucose | 2 |
| CGA | Glucose Oxidase, Glucose | 2 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 2 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 |
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 2 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 2 |
| DEL | Lipoprotein X, Antigen, Antiserum, Control | 2 |
| GFO | Activated Partial Thromboplastin | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 4, 1994 | K933694 | SIGMA GLUCOSE REAGENT Sigma Chemical Co. | CGA |
| Mar 11, 1994 | K933678 | SIGMA CALCIUM REAGENT Sigma Chemical Co. | CJY |
| Jan 3, 1994 | K933696 | SIGMA ELECTROLYTE REFERENCE REAGENT Sigma Chemical Co. | JFL |
| Dec 17, 1993 | K933691 | SIGMA CO2 ALKALINE BUFFER REAGENT Sigma Chemical Co. | JFL |
| Dec 17, 1993 | K933679 | SIGMA BUN REAGENT Sigma Chemical Co. | LFP |
| Dec 10, 1993 | K933703 | SIGMA WASH CONCENTRATE SOLUTION Sigma Chemical Co. | JJE |
| Dec 9, 1993 | K933692 | SIGMA CO2 ACID REAGENT Sigma Chemical Co. | JFL |
| Oct 22, 1993 | K933695 | SIGMA ELECTROLYTE BUFFER Sigma Chemical Co. | JFL |
| Oct 18, 1993 | K933697 | SIGMA CRE REAGENT Sigma Chemical Co. | CGX |
| Oct 13, 1993 | K933693 | SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 Sigma Chemical Co. | JIX |
| Oct 8, 1993 | K933702 | SIGMA CX-3 CALIBRATION STANDARD LEVEL 1 Sigma Chemical Co. | JIX |
| Aug 19, 1993 | K930050 | SIA THYROID STIMULATING HORMONE ELISA KIT Sigma Chemical Co. | JLW |
| Oct 31, 1991 | K901189 | MONOCLONAL ANTIBODY ANTI-CD3 Sigma Chemical Co. | GKZ |
| Oct 31, 1991 | K901188 | MONOCLONAL ANTIBODY ANTI-CD5 Sigma Chemical Co. | GKZ |
| Oct 31, 1991 | K901187 | MONOCLONAL ANTIBODY ANTI-CD2 Sigma Chemical Co. | GKZ |
| Oct 31, 1991 | K901186 | MONOCLONAL ANTIBODY ANTI-CD19 Sigma Chemical Co. | GKZ |
| Dec 18, 1990 | K904022 | NITRO BLUE TETRAZOLIUM REDUCTION Sigma Chemical Co. | GHD |
| Dec 13, 1990 | K903995 | NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT Sigma Chemical Co. | GHD |
| Nov 8, 1990 | K904341 | APTT REAGENT Sigma Chemical Co. | GFO |
| Aug 9, 1990 | K902098 | CHOLESTEROL (RATE) REAGENT Sigma Chemical Co. | CHH |
| Jul 26, 1990 | K902363 | COAGULATION CONTROL, LEVEL III Sigma Chemical Co. | GGN |
| Jul 26, 1990 | K902362 | COAGULATION CONTROL, LEVEL II Sigma Chemical Co. | GGN |
| Jul 26, 1990 | K902361 | COAGULATION CONTROL, LEVEL I Sigma Chemical Co. | GGN |
| Jul 3, 1990 | K902294 | ACCUSCAN MICROBEAD STANDARDS Sigma Chemical Co. | JIW |
| Jul 3, 1990 | K902096 | THROMBOPLASTIN WITH CALCIUM Sigma Chemical Co. | GJS |
| Apr 26, 1990 | K901675 | APOLIPOPROTEIN A-I (APO A-I) Sigma Chemical Co. | DEL |
| Mar 6, 1990 | K900906 | FACTOR II DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Mar 6, 1990 | K900412 | FACTOR XII DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Mar 6, 1990 | K900411 | FACTOR XI DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Mar 6, 1990 | K900410 | FACTOR X DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Mar 6, 1990 | K900409 | FACTOR IX DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Mar 6, 1990 | K900408 | FACTOR VIII DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Mar 6, 1990 | K900407 | FACTOR VII DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Mar 6, 1990 | K900406 | FACTOR V DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Mar 2, 1990 | K900124 | APOLIPOPROTEIN B (APO B) Sigma Chemical Co. | DEL |
| Feb 13, 1990 | K896258 | CO2 REAGENT (340 NM) Sigma Chemical Co. | KHS |
| Feb 8, 1990 | K896650 | AMYLASE REAGENT Sigma Chemical Co. | JFJ |
| Dec 1, 1989 | K896545 | ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) Sigma Chemical Co. | GFO |
| Nov 9, 1989 | K896092 | ALKALINE PHOSPHATASE, LEUKOCYTE, KIT Sigma Chemical Co. | GHD |
| Sep 5, 1989 | K894467 | THROMBIN TIME REAGENT Sigma Chemical Co. | GJA |
| Jul 20, 1989 | K893560 | ALT REAGENT (PROCEDURE NUMBER 159) Sigma Chemical Co. | CKA |
| Jun 23, 1989 | K893416 | URIC ACID REAGENT (PROCEDURE NUMBER 686) Sigma Chemical Co. | KNK |
| Jun 20, 1989 | K892844 | AST REAGENT (PROCEDURE NUMBER 158) Sigma Chemical Co. | CIT |
| Mar 28, 1989 | K885272 | CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE Sigma Chemical Co. | DIH |
| Mar 9, 1989 | K890278 | TOTAL PROTEIN REAGENT Sigma Chemical Co. | CEK |
| Nov 22, 1988 | K884574 | DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 Sigma Chemical Co. | KIT |
| Nov 22, 1988 | K884573 | HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 Sigma Chemical Co. | KIT |
| Nov 22, 1988 | K884572 | RPMI-1640 HYBRI-MAX, PROD. NO. R5382 Sigma Chemical Co. | KIT |
| Nov 10, 1988 | K883972 | MAGNESIUM REAGENT (MAGON SULFONATE) Sigma Chemical Co. | JGJ |
| Oct 25, 1988 | K883525 | OXALATE REAGENT Sigma Chemical Co. | LPW |
Newest 50 of 231.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||