510(k) K082205
K082205 is an FDA 510(k) premarket notification submitted by Genetic Testing Institute for the device "FACTOR VIII ANTIBODY SCREEN". The FDA issued a decision of Substantially Equivalent on November 20, 2008. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Genetic Testing Institute has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2008
- Date Received
- August 5, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Qualitative And Quantitative Factor Deficiency
- Device Class
- Class II
- Regulation Number
- 864.7290
- Review Panel
- HE
- Submission Type