K021123 is an FDA 510(k) clearance for the BACT/ALERT SN 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 April 26, 2002, 18 days after receiving the submission on April 8, 2002.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2560.
| 510(k) Number | K021123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2002 |
| Decision Date | April 26, 2002 |
| Days to Decision | 18 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 |