GMS
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Anti-Human Globulin, Fta-Abs Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3830
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED (K853122) | Immuno-Products Industries | 1985-09-19 |
| FLUORESCENT TREPONEMEL ANTIBODY-ABSORB (K843613) | Immuno-Products Industries | 1984-10-31 |
| FTA-ABS TEST SYSTEM (K781403) | Zeus Scientific, Inc. | 1978-08-21 |
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Every clearance here is in the API, with alerts when new ones post.