K812286 is an FDA 510(k) clearance for the MINITECK ENTERIC BROTH & ENTEROBACTER. This device is classified as a Kit, Identification, Enterobacteriaceae (Class I - General Controls, product code JSS).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on October 2, 1981, 50 days after receiving the submission on August 13, 1981.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K812286 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1981 |
| Decision Date | October 02, 1981 |
| Days to Decision | 50 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 |