Antiserum, Positive Control, Blastomyces Dermatitidis
FDA product code KFH · Class II (moderate risk) · 21 CFR 866.3060 · Microbiology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880029 | Exo-Antigen Identification System Cat.# EX1001KFH · Traditional | Immuno-Mycologics, Inc. | 02/24/1988SE |
| K792685 | Blastomyces Dermatitidis, AntiserumKFH · Traditional | Meridian Diagnostics, Inc. | 01/17/1980SE |
| K792681 | Blastomyces Dermatitidis Pos/ControlKFH · Traditional | Meridian Diagnostics, Inc. | 01/17/1980SE |
| K760833 | Anti-Blastomyces Control Serum (Yeast)KFH · Traditional | I M, Inc. | 11/01/1976SE |