K781427 is an FDA 510(k) clearance for the MS-2 BACTERIAL ID. SYSTEM. This device is classified as a Kit, Identification, Enterobacteriaceae (Class I - General Controls, product code JSS).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 27, 1978, 36 days after receiving the submission on August 22, 1978.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K781427 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1978 |
| Decision Date | September 27, 1978 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSS — Kit, Identification, Enterobacteriaceae |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |