BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO— 510(k) K161816

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K161816 for BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO, Substantially Equivalent on 2017-03-28. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code MDB
Advisory panel: Microbiology
Date received: 2016-07-01
Decision date: 2017-03-28
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.