K792681 is an FDA 510(k) clearance for the BLASTOMYCES DERMATITIDIS POS/CONTROL. This device is classified as a Antiserum, Positive Control, Blastomyces Dermatitidis (Class II - Special Controls, product code KFH).
Submitted by Meridian Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1980, 21 days after receiving the submission on December 27, 1979.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3060.
| 510(k) Number | K792681 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1979 |
| Decision Date | January 17, 1980 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | KFH — Antiserum, Positive Control, Blastomyces Dermatitidis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3060 |