GMH
5 FDA 510(k) clearances · Product code
21 daysmedian time to decision
36 days90th percentile
5clearances measured
FDA profile
- Official device name
- Antiserum, Positive Control, 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 IMMITIS, ANTISERUM POS. (K792717) | Meridian Diagnostics, Inc. | 1980-01-17 |
| COCCIDIOIDES IMMITIS, ANTISERUM (K792688) | Meridian Diagnostics, Inc. | 1980-01-17 |
| COCCIDIOIDES IMMITIS, ANTISERUM, (K792684) | Meridian Diagnostics, Inc. | 1980-01-17 |
| ANTI-COCCIDIOIDES SERUM #CF10028X (K791388) | Immuno-Mycologics, Inc. | 1979-08-16 |
| ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL) (K760834) | I M, Inc. | 1976-11-01 |
Track GMH automatically
Every clearance here is in the API, with alerts when new ones post.