VITEK REVEAL GN AST Assay and VITEK REVEAL AST System— 510(k) K260160
Substantially EquivalentbioMerieux, Inc.
FDA 510(k) clearance K260160 for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System, Substantially Equivalent on 2026-07-08. Applicant: bioMerieux, Inc.. Device class: 2.
Summary
bioMerieux's clearance covers the VITEK REVEAL GN AST Assay and the VITEK REVEAL AST System, filed under SAN, automated antimicrobial susceptibility test systems for positive blood culture samples. The record doesn't expand "GN" or list the antimicrobials.
Class II, 21 CFR 866.1650. Microbiology is both the classification panel and the review panel. It was a Traditional 510(k).
bioMerieux filed from Hazelwood, Missouri. The decision came 169 calendar days after receipt (January 20 to July 8, 2026).
Clearance details
- Applicant
- bioMerieux, Inc.
- Product code
- Product code SAN
- Device class
- Class 2
- Regulation
- 21 CFR 866.1650
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazelwood, MO, US
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More clearances from bioMerieux, Inc.
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