BACT/ALERT FN PLUS CULTURE BOTTLE— 510(k) K121455

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K121455 for BACT/ALERT FN PLUS CULTURE BOTTLE, Substantially Equivalent on 2013-01-25. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code MDB
Advisory panel: Microbiology
Date received: 2012-05-16
Decision date: 2013-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, 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.