DeviceClearance

K212243

Substantially Equivalent

VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)

Applicant
bioMerieux, Inc.
Product code
LON
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
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, through . 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.