KFH — Antiserum, Positive Control, Blastomyces Dermatitidis Class II
FDA product code KFH covers "Antiserum, Positive Control, Blastomyces Dermatitidis", a Class II medical device regulated under 21 CFR 866.3060. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KFH
- Device Class
- Class II
- Regulation Number
- 866.3060
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K880029 | immuno-mycologics | EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 | February 24, 1988 |
| K792681 | meridian diagnostics | BLASTOMYCES DERMATITIDIS POS/CONTROL | January 17, 1980 |
| K792685 | meridian diagnostics | BLASTOMYCES DERMATITIDIS, ANTISERUM | January 17, 1980 |
| K760833 | i m | ANTI-BLASTOMYCES CONTROL SERUM (YEAST) | November 1, 1976 |