Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sigma Chemical Co. · Predicate Candidate Screening
231 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
86 days90th percentile
231clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933694 | SIGMA GLUCOSE REAGENT | Sigma Chemical Co. | 1994-11-04 | 463 | 0 |
| K933678 | SIGMA CALCIUM REAGENT | Sigma Chemical Co. | 1994-03-11 | 225 | 0 |
| K933696 | SIGMA ELECTROLYTE REFERENCE REAGENT | Sigma Chemical Co. | 1994-01-03 | 158 | 0 |
| K933679 | SIGMA BUN REAGENT | Sigma Chemical Co. | 1993-12-17 | 142 | 0 |
| K933691 | SIGMA CO2 ALKALINE BUFFER REAGENT | Sigma Chemical Co. | 1993-12-17 | 141 | 0 |
| K933703 | SIGMA WASH CONCENTRATE SOLUTION | Sigma Chemical Co. | 1993-12-10 | 134 | 0 |
| K933692 | SIGMA CO2 ACID REAGENT | Sigma Chemical Co. | 1993-12-09 | 133 | 0 |
| K933695 | SIGMA ELECTROLYTE BUFFER | Sigma Chemical Co. | 1993-10-22 | 85 | 0 |
| K933697 | SIGMA CRE REAGENT | Sigma Chemical Co. | 1993-10-18 | 81 | 0 |
| K933693 | SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 | Sigma Chemical Co. | 1993-10-13 | 76 | 0 |
| K933702 | SIGMA CX-3 CALIBRATION STANDARD LEVEL 1 | Sigma Chemical Co. | 1993-10-08 | 71 | 0 |
| K930050 | SIA THYROID STIMULATING HORMONE ELISA KIT | Sigma Chemical Co. | 1993-08-19 | 226 | 0 |
| K901188 | MONOCLONAL ANTIBODY ANTI-CD5 | Sigma Chemical Co. | 1991-10-31 | 597 | 0 |
| K901187 | MONOCLONAL ANTIBODY ANTI-CD2 | Sigma Chemical Co. | 1991-10-31 | 597 | 0 |
| K901186 | MONOCLONAL ANTIBODY ANTI-CD19 | Sigma Chemical Co. | 1991-10-31 | 597 | 0 |
| K901189 | MONOCLONAL ANTIBODY ANTI-CD3 | Sigma Chemical Co. | 1991-10-31 | 597 | 0 |
| K904022 | NITRO BLUE TETRAZOLIUM REDUCTION | Sigma Chemical Co. | 1990-12-18 | 110 | 0 |
| K903995 | NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT | Sigma Chemical Co. | 1990-12-13 | 106 | 0 |
| K904341 | APTT REAGENT | Sigma Chemical Co. | 1990-11-08 | 49 | 0 |
| K902098 | CHOLESTEROL (RATE) REAGENT | Sigma Chemical Co. | 1990-08-09 | 93 | 0 |
| K902363 | COAGULATION CONTROL, LEVEL III | Sigma Chemical Co. | 1990-07-26 | 58 | 0 |
| K902362 | COAGULATION CONTROL, LEVEL II | Sigma Chemical Co. | 1990-07-26 | 58 | 0 |
| K902361 | COAGULATION CONTROL, LEVEL I | Sigma Chemical Co. | 1990-07-26 | 58 | 0 |
| K902294 | ACCUSCAN MICROBEAD STANDARDS | Sigma Chemical Co. | 1990-07-03 | 42 | 0 |
| K902096 | THROMBOPLASTIN WITH CALCIUM | Sigma Chemical Co. | 1990-07-03 | 56 | 0 |
| K901675 | APOLIPOPROTEIN A-I (APO A-I) | Sigma Chemical Co. | 1990-04-26 | 16 | 0 |
| K900406 | FACTOR V DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | 36 | 0 |
| K900407 | FACTOR VII DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | 36 | 0 |
| K900412 | FACTOR XII DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | 36 | 0 |
| K900409 | FACTOR IX DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | 36 | 0 |
| K900410 | FACTOR X DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | 36 | 0 |
| K900906 | FACTOR II DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | 7 | 0 |
| K900408 | FACTOR VIII DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | 36 | 0 |
| K900411 | FACTOR XI DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | 36 | 0 |
| K900124 | APOLIPOPROTEIN B (APO B) | Sigma Chemical Co. | 1990-03-02 | 52 | 0 |
| K896258 | CO2 REAGENT (340 NM) | Sigma Chemical Co. | 1990-02-13 | 106 | 0 |
| K896650 | AMYLASE REAGENT | Sigma Chemical Co. | 1990-02-08 | 76 | 0 |
| K896545 | ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) | Sigma Chemical Co. | 1989-12-01 | 14 | 0 |
| K896092 | ALKALINE PHOSPHATASE, LEUKOCYTE, KIT | Sigma Chemical Co. | 1989-11-09 | 21 | 0 |
| K894467 | THROMBIN TIME REAGENT | Sigma Chemical Co. | 1989-09-05 | 49 | 0 |
| K893560 | ALT REAGENT (PROCEDURE NUMBER 159) | Sigma Chemical Co. | 1989-07-20 | 72 | 0 |
| K893416 | URIC ACID REAGENT (PROCEDURE NUMBER 686) | Sigma Chemical Co. | 1989-06-23 | 52 | 0 |
| K892844 | AST REAGENT (PROCEDURE NUMBER 158) | Sigma Chemical Co. | 1989-06-20 | 63 | 0 |
| K885272 | CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE | Sigma Chemical Co. | 1989-03-28 | 96 | 0 |
| K890278 | TOTAL PROTEIN REAGENT | Sigma Chemical Co. | 1989-03-09 | 50 | 0 |
| K884573 | HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 | Sigma Chemical Co. | 1988-11-22 | 21 | 0 |
| K884572 | RPMI-1640 HYBRI-MAX, PROD. NO. R5382 | Sigma Chemical Co. | 1988-11-22 | 21 | 0 |
| K884574 | DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 | Sigma Chemical Co. | 1988-11-22 | 21 | 0 |
| K883972 | MAGNESIUM REAGENT (MAGON SULFONATE) | Sigma Chemical Co. | 1988-11-10 | 51 | 0 |
| K883525 | OXALATE REAGENT | Sigma Chemical Co. | 1988-10-25 | 69 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda