Gamma Biologicals, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Gamma Biologicals, Inc.” (first 1976, latest 1986), across 17 product codes in 5 review panels. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| KHE | Reagent, Occult Blood | 2 | 2 |
| KSI | Lectins And Protectins | 2 | 2 |
| KSX | Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use | 2 | 2 |
| KTN | System, Test, Infectious Mononucleosis | 2 | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| GMT | Antigens, Ha, Treponema Pallidum | 1 | 1 |
| GSZ | Antigens, Febrile (Weil-Felix), All Groups | 1 | 1 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | 1 |
Plus 7 more product codes.
Review panels
- Hematology (10)
- Microbiology (6)
- Immunology (3)
- Clinical Chemistry (1)
- Pathology (1)
Most recent Gamma Biologicals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K864207 | DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO | KTN | 1986-12-03 | 37 |
| K861016 | GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS | KTN | 1986-04-18 | 31 |
| K832473 | GAMMA SLIDE TEST FOR PREGNANCY | JHJ | 1983-08-16 | 21 |
| K820647 | GAMMA FETAL BLEED SCREENING TEST | LIM | 1982-05-12 | 64 |
| K820072 | FE-CULT PLUS | KHE | 1982-03-04 | 51 |
| K813342 | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION | KSK | 1982-03-04 | 99 |
| K811752 | FE-CULT PLUS | KHE | 1981-11-02 | 133 |
| K802534 | GAMMA PI BLOOD GROUP SUBSTANCE | KSX | 1980-11-12 | 28 |
| K802533 | GAMMA LEWIS BLOOD GROUP SUBSTANCE | KSX | 1980-11-12 | 28 |
| K800658 | RST-SERIES CONTROL | KSF | 1980-04-16 | 21 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gamma Biologicals, 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 Enterprises, Inc. (23 510(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 Biologicals, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Gamma Biologicals, Inc.” (first 1976, latest 1986), across 17 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 Gamma Biologicals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gamma Biologicals, Inc. is 50 days.
Which FDA product codes appear under Gamma Biologicals, Inc.?
The most frequent FDA product codes under this applicant name are KHE (Reagent, Occult Blood, 2); KSI (Lectins And Protectins, 2); KSX (Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use, 2).
Next steps
- See all 21 Gamma Biologicals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KHE, Gamma Biologicals, 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.