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510(k) K073071

EQ-PRC LC WARFARIN GENOTYPING KIT by Trimgen Corporation — Product Code ODW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2009
Date Received
October 31, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Device Class
Class II
Regulation Number
862.3360
Review Panel
TX
Submission Type

An in vitro diagnostic assay for use in genotyping Cytochrome P450 2C9 (CYP450 2C9) alleles. Information about the CYP2C9 genotype may be used as an aid to clinicians in determining therapeutic strategy for medications that are metabolized by the CYP2C9 gene product.

Other clearances for product code ODW

  • K183530 — TruDiagnosis System (May 24, 2019)
  • K152612 — eSensor Warfarin Sensitivity Saliva Test (May 26, 2016)
  • K073720 — ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT (July 17, 2008)
  • K073014 — INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN (January 23, 2008)
  • K070804 — VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST (September 17, 2007)