510(k) K073014
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.