510(k) K132978
K132978 is an FDA 510(k) premarket notification submitted by Sequenom, Inc. for the device "IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST". The FDA issued a decision of Substantially Equivalent on June 13, 2014. The device falls under product code PHJ (System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations), a Class II device regulated under 21 CFR 864.7280.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2014
- Date Received
- September 23, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
- Device Class
- Class II
- Regulation Number
- 864.7280
- Review Panel
- PA
- Submission Type
A multiplex genotying test system intended for the qualitative detection and identification of specific thrombophilia related gene mutations from genomic DNA by genomic amplification and mass spectrometry. It is intended as an aid in diagnosis of patients with suspected thrombophilia.