Sigma Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 164 510(k) clearances under the applicant name “Sigma Diagnostics, Inc.” (first 1984, latest 2002), across 95 product codes in 6 review panels. Median 510(k) review time under this name: 55 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 8 | 8 |
| LJG | Quality Control Slides | 7 | 7 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 5 | 5 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 4 | 4 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 4 | 4 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 4 | 4 |
| GJT | Plasma, Coagulation Factor Deficient | 4 | 4 |
| CFR | Hexokinase, Glucose | 3 | 3 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 3 | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 3 | 3 |
Plus 85 more product codes.
Review panels
- Clinical Chemistry (77)
- Hematology (42)
- Clinical Toxicology (25)
- Microbiology (8)
- Pathology (8)
- Immunology (4)
Most recent Sigma Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021162 | AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED | JPA | 2002-08-30 | 141 |
| K020109 | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL | GGC | 2002-02-06 | 26 |
| K013549 | SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 | DAP | 2001-12-26 | 63 |
| K013545 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 | DAP | 2001-11-15 | 22 |
| K013544 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 | DAP | 2001-11-15 | 22 |
| K012410 | INFINITY HBA KIT, MODELS 537-A, 537-B | LCP | 2001-10-26 | 88 |
| K010652 | SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 | JIX | 2001-03-30 | 25 |
| K010158 | THROMBOMAX-HS WITH CALCIUM, MODEL T6540 | GGO | 2001-03-22 | 64 |
| K003267 | SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A | DAP | 2001-03-15 | 148 |
| K003329 | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 | GGC | 2001-03-01 | 128 |
154 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sigma Diagnostics, Inc..
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 Diagnostics, Inc. (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 Chemical Co. (231 510(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 Diagnostics, Inc.?
FDA lists 164 510(k) clearances under the applicant name “Sigma Diagnostics, Inc.” (first 1984, latest 2002), across 95 product codes in 6 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 Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sigma Diagnostics, Inc. is 55 days.
Which FDA product codes appear under Sigma Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JPA (System, Multipurpose For In Vitro Coagulation Studies, 8); LJG (Quality Control Slides, 7); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 5).
Next steps
- See all 164 Sigma Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JPA, Sigma Diagnostics, Inc.'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.