EQ-PRC LC WARFARIN GENOTYPING KIT— 510(k) K073071

Name: FDA 510(k) clearance K073071
Creator: U.S. Food and Drug Administration
Published: 2009-02-06

Substantially Equivalent

Trimgen Corporation

FDA 510(k) clearance K073071 for EQ-PRC LC WARFARIN GENOTYPING KIT, Substantially Equivalent on 2009-02-06. Applicant: Trimgen Corporation. Device class: 2.

Clearance details

Applicant: Trimgen Corporation
Product code: Code ODW
Device class: Class 2
Regulation: 21 CFR 862.3360
Advisory panel: Clinical Toxicology
Date received: 2007-10-31
Decision date: 2009-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

Download summary PDF View on FDA.gov ↗

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