VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL)— 510(k) K212849

Substantially Equivalent

Biomérieux, Inc.

FDA 510(k) clearance K212849 for VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL), Substantially Equivalent on 2022-02-04. Applicant: Biomérieux, Inc..

Clearance details

Applicant: Biomérieux, Inc.
Product code: Code LON
Advisory panel: Microbiology
Date received: 2021-09-07
Decision date: 2022-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LON

product code LON

Malfunction: 2,383
Total: 2,383

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.