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

Clearance details

Applicant

bioMerieux, Inc.

Product code

Code QAT

Device class

Class 2

Regulation

21 CFR 866.5830

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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