K802309 is an FDA 510(k) clearance for the MS-2 IDENTIFICATION SYSTEM. This device is classified as a Kit, Identification, Yeast (Class I - General Controls, product code JXB).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 1, 1980, 69 days after receiving the submission on September 23, 1980.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K802309 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 1980 |
| Decision Date | December 01, 1980 |
| Days to Decision | 69 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 |