K800908 is an FDA 510(k) clearance for the CAPIK-CANDIDA ALBICANS IDENT. KIT.. This device is classified as a Kit, Identification, Yeast (Class I - General Controls, product code JXB).
Submitted by Immuno-Mycologics, Inc. (Walker, US). The FDA issued a Cleared decision on June 2, 1980, 42 days after receiving the submission on April 21, 1980.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K800908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 1980 |
| Decision Date | June 02, 1980 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JXB — Kit, Identification, Yeast |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |