510(k) DEN030005
DEN030005 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "FACTOR V LEIDEN KIT". The FDA issued a decision of De Novo Granted on December 17, 2003. The device falls under product code NPQ (Test, Factor V Leiden Mutations, Genomic Dna Pcr), a Class II device regulated under 21 CFR 864.7280. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
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.