FDA 510(k) clearance · back to tracker

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

bioMerieux, Inc. cleared K260160 on 2026-07-08, decision: substantially equivalent

K-number

K260160

Sponsor

bioMerieux, Inc.

Device

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-08

Product code

SAN

Advisory committee

Microbiology

Medical specialty

Microbiology

Regulation number

866.1650

Official FDA record

Open K260160on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.