BacT/ALERT FA Plus; BacT/ALERT PF Plus— 510(k) K183166

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K183166 for BacT/ALERT FA Plus; BacT/ALERT PF Plus, Substantially Equivalent on 2019-02-11. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code MDB
Advisory panel: Microbiology
Date received: 2018-11-15
Decision date: 2019-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MDB

product code MDB

Death: 6
Malfunction: 5,490
Total: 5,496

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.