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

Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

21 CFR 862.3360 / Clinical Toxicology
FDA source (opens on fda.gov)

ODW is the FDA product code for Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System, a class II device type, regulated under 21 CFR 862.3360. FDA's definition for this code reads: "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". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
ODW
Device name
Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
FDA definition
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.
Regulation
21 CFR 862.3360
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
1

Clearances, product code ODW

By decision year
6 clearances under product code ODW with a decision year between 2007 and 2019, 2008 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code ODW by decision year
YearClearances
20071
20082
20091
20161
20191

Applicants with the most clearances

Product code ODW
Applicants holding the most 510(k) clearances under product code ODW
ApplicantClearances
Akonni Biosystems, Inc.1
Autogenomics, Incorporated1
Genmark Diagnostics, Incorporated1
Luminex Corporation1
Osmetech Molecular Diagnostics1
Trimgen Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code