INFINITI CYP2C19 ASSAY— 510(k) K101683

Name: FDA 510(k) clearance K101683
Creator: U.S. Food and Drug Administration
Published: 2010-10-25

Substantially Equivalent

Autogenomics, Incorporated

FDA 510(k) clearance K101683 for INFINITI CYP2C19 ASSAY, Substantially Equivalent on 2010-10-25. Applicant: Autogenomics, Incorporated. Device class: 2.

Clearance details

Applicant: Autogenomics, Incorporated
Product code: Code NTI
Device class: Class 2
Regulation: 21 CFR 862.3360
Advisory panel: Clinical Toxicology
Date received: 2010-06-15
Decision date: 2010-10-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

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