510(k) K082118
K082118 is an FDA 510(k) premarket notification submitted by Cepheid for the device "XPERT HEMOSIL FACTOR II & FACTOR V ASSAY". The FDA issued a decision of Substantially Equivalent on September 18, 2009. 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. Cepheid has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2009
- Date Received
- July 28, 2008
- Clearance Type
- Traditional
- 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.