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FDA 510(k) K230675 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
FDA 510(k) index record K230675. Device: VITEK REVEAL GN AST Assay and VITEK REVEAL AST System. Applicant as listed: Specific Diagnostics, LLC. Decision date: 2024-06-20.
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"device_name": "VITEK REVEAL GN AST Assay and VITEK REVEAL AST System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K230675.
Device name: VITEK REVEAL GN AST Assay and VITEK REVEAL AST System. Applicant as listed: Specific Diagnostics, LLC.
Decision date: 2024-06-20. Decision wording: Substantially Equivalent.
Product code: SAN. Regulation: 21 CFR 866.1650. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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