FDA 510(k)

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

K-Number: K230675 · 2024-06-20

Decision Date2024-06-20

Product CodeSAN

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is a medical device manufactured by Specific Diagnostics, LLC. It received FDA 510(k) clearance on 2024-06-20 under approval number K230675. The device is classified under product code SAN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITEK REVEAL GN AST Assay and VITEK REVEAL AST System?

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is a medical device that received FDA 510(k) clearance on 2024-06-20. It is manufactured by Specific Diagnostics, LLC. The 510(k) number is K230675.

When was VITEK REVEAL GN AST Assay and VITEK REVEAL AST System approved by the FDA?

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System received FDA 510(k) clearance on 2024-06-20, under approval number K230675.

What company makes VITEK REVEAL GN AST Assay and VITEK REVEAL AST System?

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is manufactured by Specific Diagnostics, LLC.

What is the FDA product code for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System?

The FDA product code for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is SAN.

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.