Gamma Biologicals, Inc.
Medical device manufacturer in Houston, TX.
21510(k) clearances
0PMA approvals
0recalls
Device types
- KTN System, Test, Infectious Mononucleosis 2
- KHE Reagent, Occult Blood 2
- KSX Substance, Blood Grouping Of Non-Human… 2
- KSI Lectins And Protectins 2
- KSG Media, Potentiating For In Vitro Diagnostic… 1
- JHJ Agglutination Method, Human Chorionic… 1
- LIM Test, Screening, For D Positive Fetal Rbc'S 1
- KSK Solution, Stabilized Enzyme 1
- KSF Kit, Quality Control For Blood Banking… 1
- KIN Slide Stainer, Contact Type 1
- DEM Alpha-1-Antitrypsin, Antigen, Antiserum… 1
- GMT Antigens, Ha, Treponema Pallidum 1
- GSZ Antigens, Febrile (Weil-Felix), All Groups 1
- GTQ Antistreptolysin - Titer/Streptolysin O… 1
- DHR System, Test, Rheumatoid Factor 1
- DCK C-Reactive Protein, Antigen, Antiserum, And… 1
- GTZ Antisera, All Groups, Streptococcus Spp. 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K864207 | Disposable Test Cards/Gamma Slide Test Infect MonoKTN · Traditional | 12/03/1986SE |
| K861016 | Gamma Slide Test for Infectious MononucleosisKTN · Traditional | 04/18/1986SE |
| K832473 | Gamma Slide Test for PregnancyJHJ · Traditional | 08/16/1983SE |
| K820647 | Gamma Fetal Bleed Screening TestLIM · Traditional | 05/12/1982SE |
| K820072 | Fe-Cult PlusKHE · Traditional | 03/04/1982SE |
| K813342 | Gamma Chloroquine Diphosphate SolutionKSK · Traditional | 03/04/1982SE |
| K811752 | Fe-Cult PlusKHE · Traditional | 11/02/1981SE |
| K802534 | Gamma Pi Blood Group SubstanceKSX · Traditional | 11/12/1980SE |
| K802533 | Gamma Lewis Blood Group SubstanceKSX · Traditional | 11/12/1980SE |
| K800658 | Rst-Series ControlKSF · Traditional | 04/16/1980SE |
| K792583 | Gamma Arachis Hypogea LectinKSI · Traditional | 01/16/1980SE |
| K792582 | Poly-Lec SystemKSI · Traditional | 01/16/1980SE |
| K790973 | Lo-IonKSG · Traditional | 06/15/1979SE |
| K760034 | Test, Strep, Latex SlideDEM · Traditional | 08/11/1976SE |
| K760098 | Reagent, VDRLGMT · Traditional | 08/03/1976SE |
| K760097 | Febrile Antigens & Control SerumsGSZ · Traditional | 08/03/1976SE |
| K760096 | Reagent, Lyophilized Anti-Streptolysin OGTQ · Traditional | 08/03/1976SE |
| K760036 | Test, Latex Slide, Rheumatoid FactorDHR · Traditional | 08/03/1976SE |
| K760035 | Test, C-Reative Protein, Latex SlideDCK · Traditional | 08/03/1976SE |
| K760033 | Test, Antibodies for GRP a, Latex SlideGTZ · Traditional | 08/03/1976SE |
| K760032 | Test, Mono., Differential SlideKIN · Traditional | 08/03/1976SE |