GMT
9 FDA 510(k) clearances · Product code
107 daysmedian time to decision
206 days90th percentile
9clearances measured
FDA profile
- Official device name
- Antigens, Ha, Treponema Pallidum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3830
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1994: 1 · 1997: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SERODIA TP-PA (K971502) | Scimedx Tekfile Services | 1997-11-13 |
| OLYMPUS PK TP(TM) SYSTEM, MODIFICATION (K911640) | Olympus Corp. | 1991-07-24 |
| MODIFIED PK TP CONTROL (K911266) | Olympus Corp. | 1991-05-07 |
| OLYMPUS PK-TP ABSORBENT KIT (K905038) | Fujirebio America, Inc. | 1991-05-06 |
| CELLOGNOST SYPHILIS H (K896410) | Behring Diagnostics, Inc. | 1990-05-15 |
| OLYMPUS PK(TM) TP (K893124) | Fujirebio Diagnostics,Inc. | 1989-11-17 |
| BACTO-HATTS (K791897) | Difco Laboratories, Inc. | 1979-11-13 |
| AGGLUTINOTEST-SYPHILIS (K791457) | Volu Sol Medical Industries | 1979-09-24 |
| REAGENT, VDRL (K760098) | Gamma Biologicals, Inc. | 1976-08-03 |
Track GMT automatically
Every clearance here is in the API, with alerts when new ones post.