ODV · Class II · 21 CFR 864.7750

FDA Product Code ODV: Vitamin K Epoxide Reductase Complex Subunit One (vkorc1) Genotyping System

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.

1
Total
1
Cleared
297d
Avg days
2008
Since

FDA 510(k) Cleared Vitamin K Epoxide Reductase Complex Subunit One (vkorc1) Genotyping System Devices (Product Code ODV)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code ODV - Regulatory Context