K792716 is an FDA 510(k) clearance for the CANDIDA ALBICANS, ANTIGEN. This device is classified as a Antigen, Cf And / Or Id, Coccidioides Immitis (Class II - Special Controls, product code GMI).
Submitted by Meridian Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 24, 1980, 28 days after receiving the submission on December 27, 1979.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3135.
| 510(k) Number | K792716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1979 |
| Decision Date | January 24, 1980 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GMI — Antigen, Cf And / Or Id, Coccidioides Immitis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3135 |