K240279

Substantially Equivalent

VIDAS TBI (GFAP, UCH-L1)

Applicant: bioMerieux, Inc.
Product code: QAT
Advisory panel: Immunology
Date received: 2024-02-01
Decision date: 2024-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

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