K183166 is an FDA 510(k) clearance for the BacT/ALERT FA Plus. This device is classified as a System, Blood Culturing (Class I - General Controls, product code MDB).
Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on February 11, 2019, 88 days after receiving the submission on November 15, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2560.
| 510(k) Number | K183166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2018 |
| Decision Date | February 11, 2019 |
| Days to Decision | 88 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 |