K190405 is an FDA 510(k) clearance for the BACT/ALERT MP Reagent System. 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 May 15, 2019, 85 days after receiving the submission on February 19, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2560.
| 510(k) Number | K190405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2019 |
| Decision Date | May 15, 2019 |
| Days to Decision | 85 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 |