KFH
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antiserum, Positive Control, Blastomyces Dermatitidis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3060
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 (K880029) | Immuno-Mycologics, Inc. | 1988-02-24 |
| BLASTOMYCES DERMATITIDIS, ANTISERUM (K792685) | Meridian Diagnostics, Inc. | 1980-01-17 |
| BLASTOMYCES DERMATITIDIS POS/CONTROL (K792681) | Meridian Diagnostics, Inc. | 1980-01-17 |
| ANTI-BLASTOMYCES CONTROL SERUM (YEAST) (K760833) | I M, Inc. | 1976-11-01 |
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Every clearance here is in the API, with alerts when new ones post.