Gamma Enterprises, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Gamma Enterprises, Inc.” (first 1977, latest 1979), across 21 product codes in 2 review panels. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CGO | Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
Plus 11 more product codes.
Review panels
Most recent Gamma Enterprises, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K790578 | GAMMA SMAC REAGENTS | CIG | 1979-05-15 | 49 |
| K780507 | SERUM GLUTAMIC-PYRUVIC TRANSAMINASE | CKC | 1978-05-03 | 34 |
| K780506 | CARBON DIOXIDE REAGENTS | KMS | 1978-05-03 | 34 |
| K780505 | SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE | CIT | 1978-05-03 | 34 |
| K780504 | CREATINE PHOSPHOKINASE (CPK) | JHS | 1978-05-03 | 34 |
| K771843 | WETTING AGENTS | — | 1977-11-22 | 62 |
| K771836 | LACTATE DEHYDROGENASE | CFJ | 1977-11-22 | 62 |
| K771832 | CHLORIDE | JFS | 1977-11-22 | 62 |
| K771838 | SERUM IRON | JIY | 1977-11-03 | 43 |
| K771834 | CREATININE | CGX | 1977-11-03 | 43 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gamma Enterprises, 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.
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.
- Gamma Biologicals, Inc. (21 510(k)s)
- Gamma Medica-Ideas Incorporated (2 510(k)s)
- Gamma Medical Products, Inc. (2 510(k)s)
- Gamma Medica (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gamma Enterprises, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Gamma Enterprises, Inc.” (first 1977, latest 1979), across 21 product codes in 2 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 Gamma Enterprises, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gamma Enterprises, Inc. is 34 days.
Which FDA product codes appear under Gamma Enterprises, Inc.?
The most frequent FDA product codes under this applicant name are CIG (Diazo Colorimetry, Bilirubin, 2); CDH (Acid, Uric, Phosphotungstate Reduction, 1); CDW (Diacetyl-Monoxime, Urea Nitrogen, 1).
Next steps
- See all 23 Gamma Enterprises, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CIG, Gamma Enterprises, 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.