Sigma Chemical Co.: FDA filings under this applicant name
FDA lists 231 510(k) clearances under the applicant name “Sigma Chemical Co.” (first 1976, latest 1994), across 93 product codes in 5 review panels. Median 510(k) review time under this name: 41 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 87 | 87 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 9 | 9 |
| GJT | Plasma, Coagulation Factor Deficient | 8 | 8 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 4 | 4 |
| GKZ | Counter, Differential Cell | 4 | 4 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 4 | 4 |
| KIP | Formulations, Balanced Salt Solutions | 4 | 4 |
| GGN | Plasma, Coagulation Control | 3 | 3 |
| GHD | Test, Leukocyte Alkaline Phosphatase | 3 | 3 |
| HYB | Eosin Y | 3 | 3 |
Plus 83 more product codes.
Review panels
- Pathology (114)
- Clinical Chemistry (66)
- Hematology (40)
- Clinical Toxicology (6)
- Immunology (3)
Most recent Sigma Chemical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933694 | SIGMA GLUCOSE REAGENT | CGA | 1994-11-04 | 463 |
| K933678 | SIGMA CALCIUM REAGENT | CJY | 1994-03-11 | 225 |
| K933696 | SIGMA ELECTROLYTE REFERENCE REAGENT | JFL | 1994-01-03 | 158 |
| K933691 | SIGMA CO2 ALKALINE BUFFER REAGENT | JFL | 1993-12-17 | 141 |
| K933679 | SIGMA BUN REAGENT | LFP | 1993-12-17 | 142 |
| K933703 | SIGMA WASH CONCENTRATE SOLUTION | JJE | 1993-12-10 | 134 |
| K933692 | SIGMA CO2 ACID REAGENT | JFL | 1993-12-09 | 133 |
| K933695 | SIGMA ELECTROLYTE BUFFER | JFL | 1993-10-22 | 85 |
| K933697 | SIGMA CRE REAGENT | CGX | 1993-10-18 | 81 |
| K933693 | SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 | JIX | 1993-10-13 | 76 |
221 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sigma Chemical Co..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Sigma Chemical Co. (a text match, not an official crosswalk):
- J7197 — Antithrombin iii (human), per i.u. (via JBQ)
- J7213 — Injection, coagulation factor ix (recombinant), ixinity, 1 i.u. (via GJT)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sigma Diagnostics, Inc. (164 510(k)s)
- Sigma Medical, Inc. (13 510(k)s)
- Sigma (6 510(k)s)
- Sigma Medical Supplies Corp. (5 510(k)s)
- Sigma Intl. (3 510(k)s)
- Sigma Cell Culture Reagents (2 510(k)s)
- Sigma Biomedical (1 510(k)s)
- Sigma Biomedics, Inc. (1 510(k)s)
- Sigma Distribution & Supply, Inc. (1 510(k)s)
- Sigma Intl. General Medical Apparatus, Inc. (1 510(k)s)
- Sigma Scientific Services, LLC (1 510(k)s)
- Sigma Teleproducts, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sigma Chemical Co.?
FDA lists 231 510(k) clearances under the applicant name “Sigma Chemical Co.” (first 1976, latest 1994), across 93 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sigma Chemical Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sigma Chemical Co. is 41 days.
Which FDA product codes appear under Sigma Chemical Co.?
The most frequent FDA product codes under this applicant name are KIT (Media And Components, Synthetic Cell And Tissue Culture, 87); GGP (Test, Qualitative And Quantitative Factor Deficiency, 9); GJT (Plasma, Coagulation Factor Deficient, 8).
Next steps
- See all 231 Sigma Chemical Co. clearances with predicates and recalls
- Run predicate analysis for product code KIT, Sigma Chemical Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.