ODW · Class II · 21 CFR 862.3360

FDA Product Code ODW: Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

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.

6
Total
6
Cleared
224d
Avg days
2007
Since

FDA 510(k) Cleared Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System Devices (Product Code ODW)

6 devices
1–6 of 6
No devices found for this product code.

About Product Code ODW - Regulatory Context