RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA— 510(k) K071867

Name: FDA 510(k) clearance K071867
Creator: U.S. Food and Drug Administration
Published: 2008-04-28

Substantially Equivalent

Paragondx, LLC

FDA 510(k) clearance K071867 for RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA, Substantially Equivalent on 2008-04-28. Applicant: Paragondx, LLC. Device class: 2.

Clearance details

Applicant: Paragondx, LLC
Product code: Code ODV
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 2007-07-06
Decision date: 2008-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

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