510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071867Substantially Equivalent

Rapid Genotyping Assay -Cyp2c9 & Vkorc1, Model Catalog No. 006+0203 Gactga

Paragondx, LLC, Morrisville NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K071867 is the FDA 510(k) clearance record for RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA, a class II device, cleared for Paragondx, LLC on under FDA product code ODV (Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System). FDA's definition for product code ODV reads: "An in vitro diagnostic assay for use in genotyping vitamin k epoxide reductase complex subunit one (VKORC1) alleles to aid in the identification of patients at risk for altered warfarin sensitivity". FDA records list one 510(k) clearance for Paragondx, LLC. As of , FDA records show no recalls naming K071867.

Clearance record

Decision date
Received
(297 days to decision)
Product code
ODV Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System
Regulation
21 CFR 864.7750
Device class
Class II
Review panel
Hematology
Applicant
Paragondx, LLC 133 Southcenter Ct., Morrisville NC
510(k) summary
Statement
Third party review
No

Clearances, product code ODV

Trailing 12 months

FDA records hold no clearances under product code ODV in the trailing twelve months.

FDA records show no clearances under product code ODV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ODV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260