K120994 is an FDA 510(k) clearance for the BD BACTEC Plus PRIME Aerobic/F Culture Vials. This device is classified as a System, Blood Culturing (Class I - General Controls, product code MDB).
Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on August 7, 2012, 127 days after receiving the submission on April 2, 2012.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2560.
| 510(k) Number | K120994 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2012 |
| Decision Date | August 07, 2012 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MDB — System, Blood Culturing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2560 |