INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN— 510(k) K073014

Name: FDA 510(k) clearance K073014
Creator: U.S. Food and Drug Administration
Published: 2008-01-23

Substantially Equivalent

Autogenomics, Incorporated

FDA 510(k) clearance K073014 for INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN, Substantially Equivalent on 2008-01-23. Applicant: Autogenomics, Incorporated. Device class: 2.

Clearance details

Applicant: Autogenomics, Incorporated
Product code: Code ODW
Device class: Class 2
Regulation: 21 CFR 862.3360
Advisory panel: Clinical Toxicology
Date received: 2007-10-25
Decision date: 2008-01-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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