K921133 is an FDA 510(k) clearance for the BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA. This device is classified as a System, Blood Culturing (Class I - General Controls, product code MDB).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on April 22, 1992, 43 days after receiving the submission on March 10, 1992.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2560.
| 510(k) Number | K921133 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1992 |
| Decision Date | April 22, 1992 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | MDB — System, Blood Culturing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2560 |