510(k) K073014
K073014 is an FDA 510(k) premarket notification submitted by Autogenomics, Incorporated for the device "INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN". The FDA issued a decision of Substantially Equivalent on January 23, 2008. The device falls under product code ODW (Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System), a Class II device regulated under 21 CFR 862.3360. Autogenomics, Incorporated has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2008
- Date Received
- October 25, 2007
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
- Device Class
- Class II
- Regulation Number
- 862.3360
- Review Panel
- TX
- Submission Type
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.