K943621 is an FDA 510(k) clearance for the RAPID YEAST PLUS SYSTEM. This device is classified as a Kit, Identification, Yeast (Class I - General Controls, product code JXB).
Submitted by Innovative Diagnostic Systems, Inc. (Atlanta, US). The FDA issued a Cleared decision on January 27, 1995, 184 days after receiving the submission on July 27, 1994.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K943621 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 1994 |
| Decision Date | January 27, 1995 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JXB — Kit, Identification, Yeast |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |