Clearance Summary
PF4 ENHANCED SOLID PHASE ELISA received FDA 510(k) clearance under submission number K053559, sponsored by Genetic Testing Institute. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2006-01-20.
- Submission: K053559
- Applicant / Sponsor: Genetic Testing Institute
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7695
- Decision date: 2006-01-20
Classification & Regulation
This clearance is catalogued under FDA product code LCO and 21 CFR 864.7695, within the Hematology review panel as a Class II device.