K830964 is an FDA 510(k) clearance for the ANAEROBE MIC/ID TEMPLATE, & TAXONOMY. This device is classified as a Kit, Anaerobic Identification (Class I - General Controls, product code JSP).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on May 4, 1983, 37 days after receiving the submission on March 28, 1983.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K830964 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1983 |
| Decision Date | May 04, 1983 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSP — Kit, Anaerobic Identification |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |