510(k) K230675— VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

Substantially Equivalent

Specific Diagnostics, LLC

Clearance details

Applicant: Specific Diagnostics, LLC
Product code: Code SAN
Advisory panel: Microbiology
Date received: 2023-03-10
Decision date: 2024-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

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