K960075 is an FDA 510(k) clearance for the CHROMAGAR CANDIDA. This device is classified as a Kit, Screening, Yeast (Class I - General Controls, product code JXC).
Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on August 2, 1996, 204 days after receiving the submission on January 11, 1996.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K960075 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 1996 |
| Decision Date | August 02, 1996 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JXC — Kit, Screening, Yeast |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |