VITEK REVEAL GN AST Assay and VITEK REVEAL AST System— 510(k) K260160

Clearance details

Applicant

bioMerieux, Inc.

Product code

Code SAN

Device class

Class 2

Regulation

21 CFR 866.1650

Advisory panel

Microbiology

Date received

2026-01-20

Decision date

2026-07-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hazelwood, MO, US

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