VIDAS TBI (GFAP, UCH-L1)— 510(k) K240279

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K240279 for VIDAS TBI (GFAP, UCH-L1), Substantially Equivalent on 2024-05-01. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: 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

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