GMG
5 FDA 510(k) clearances · Product code
22 daysmedian time to decision
51 days90th percentile
5clearances measured
FDA profile
- Official device name
- Antigen, Latex Agglutination, Coccidioides Immitis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3135
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| COCCIDIOIDES LATEX AGGLUTINATION (K812189) | American Scientific Products | 1981-08-25 |
| COCCIDIOIDES IMMITIS, LATEX AGGLUTI (K792690) | Meridian Diagnostics, Inc. | 1980-01-17 |
| COCCIDIODES (COCCI) (K791381) | Immuno-Mycologics, Inc. | 1979-08-16 |
| REAGENT, COCCI LATEX (K782070) | I M, Inc. | 1979-02-01 |
| COCCIDIOIDES MYCELIAL ANTIGEN (K760829) | I M, Inc. | 1976-11-01 |
Track GMG automatically
Every clearance here is in the API, with alerts when new ones post.