510(k) K060564
K060564 is an FDA 510(k) premarket notification submitted by AutoGenomics, Inc. for the device "INFINITI SYSTEM". The FDA issued a decision of Substantially Equivalent on February 7, 2007. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 2007
- Date Received
- March 3, 2006
- 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.