K121461 is an FDA 510(k) clearance for the BACT/ALERT FA PLUS CULTURE BOTTLE. This device is classified as a System, Blood Culturing (Class I - General Controls, product code MDB).
Submitted by bioMerieux, Inc. (Durham, US). The FDA issued a Cleared decision on January 22, 2013, 250 days after receiving the submission on May 17, 2012.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2560.
| 510(k) Number | K121461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2012 |
| Decision Date | January 22, 2013 |
| Days to Decision | 250 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 |