GTN
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antisera, Fluorescent, All Types, Staphylococcus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3700
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DIAGNOSTIC REAGENT SET-RPLA (K855233) | Oxoid U.S.A., Inc. | 1986-11-04 |
| DIAGNOSTIC REAGENT TST-RPLA (K855236) | Oxoid U.S.A., Inc. | 1986-11-04 |
| STAPHAUREX ZL30 (K851949) | Wellcome Diagnostics | 1985-05-22 |
| AGGLUTINOTEST-STAPHYLOLISIN (K791453) | Volu Sol Medical Industries | 1979-09-24 |
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Every clearance here is in the API, with alerts when new ones post.