510(k) DEN030005
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 17, 2003
- Date Received
- December 8, 2003
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Factor V Leiden Mutations, Genomic Dna Pcr
- Device Class
- Class II
- Regulation Number
- 864.7280
- Review Panel
- PA
- Submission Type
In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.