GMI
11 FDA 510(k) clearances · Product code
28 daysmedian time to decision
103 days90th percentile
11clearances measured
FDA profile
- Official device name
- Antigen, Cf And / Or Id, 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 |
|---|---|---|
| OLYMPUS PK-TP SYSTEM REACTIVE CONTROL (K894617) | Schiff & Co. | 1989-10-31 |
| COCCIDIOIDES IMMUNODIFFUSION SYSTEM (K812190) | American Scientific Products | 1981-08-31 |
| FUNGAL IMMUNODIFFUSION SYSTEM (K812185) | American Scientific Products | 1981-08-25 |
| IMMUNODIFFUSION REAGENTS/SEROLOGICAL (K802129) | Nolan Biological Laboratories, Inc. | 1980-09-26 |
| CANDIDA ALBICANS, ANTIGEN (K792716) | Meridian Diagnostics, Inc. | 1980-01-24 |
| CANDIDA ALBICANS, ANTISERUM (K792713) | Meridian Diagnostics, Inc. | 1980-01-23 |
| COCCIDIOIDES IMMITIS, ANTIGEN (K792689) | Meridian Diagnostics, Inc. | 1980-01-17 |
| COCCIDIOIDES IMMITIS, ANTIGEN (K792682) | Meridian Diagnostics, Inc. | 1980-01-17 |
| COCCIDIOIDES ANTIGEN #CF10023X (K791389) | Immuno-Mycologics, Inc. | 1979-08-16 |
| CANDIDA IMMUNODIFFUSION KIT #CA1001 (K791383) | Immuno-Mycologics, Inc. | 1979-08-16 |
| CANDIDA IMMUNODIFFUSION KIT (K770527) | I M, Inc. | 1978-03-17 |
Track GMI automatically
Every clearance here is in the API, with alerts when new ones post.