GMM
8 FDA 510(k) clearances · Product code
147 daysmedian time to decision
162 days90th percentile
8clearances measured
FDA profile
- Official device name
- Antigens, Iha, Toxoplasma Gondii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3780
- 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 |
|---|---|---|
| TOXOGEN (K981263) | Instrumentation Laboratory CO | 1998-08-06 |
| ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII (K952818) | Pyramid Biological Corp. | 1995-11-20 |
| HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT (K851977) | Si Sero-Immuno Diagnostics, Inc. | 1985-10-16 |
| HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT (K851976) | Si Sero-Immuno Diagnostics, Inc. | 1985-10-16 |
| POLYCHACO INDIRECT HEMAGGLUTINATION (K830870) | Parasitic Disease Consultants | 1983-08-12 |
| TOXOTEST-MT EIKEN KIT (K802452) | Syn-Kit, Inc. | 1980-12-18 |
| TXOCELL-IHA REAGENT SYSTEM (K790460) | Calbiochem-Behring Corp. | 1979-05-25 |
| TOXHA TEST (K771560) | Burroughs Wellcome Co. | 1977-09-15 |
Track GMM automatically
Every clearance here is in the API, with alerts when new ones post.