LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system— 510(k) K251875

Name: FDA 510(k) clearance K251875
Creator: U.S. Food and Drug Administration
Published: 2025-10-27

Substantially Equivalent

Affinity Biosensors, LLC

FDA 510(k) clearance K251875 for LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system, Substantially Equivalent on 2025-10-27. Applicant: Affinity Biosensors, LLC. Device class: 2.

Clearance details

Applicant: Affinity Biosensors, LLC
Product code: Code SAN
Device class: Class 2
Regulation: 21 CFR 866.1650
Advisory panel: Microbiology
Date received: 2025-06-18
Decision date: 2025-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

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K241324 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system2024-10-23
K230675 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System2024-06-20

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