Clearance Summary
HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY received FDA 510(k) clearance under submission number K040293, sponsored by Akers Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2004-05-28.
- Submission: K040293
- Applicant / Sponsor: Akers Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7695
- Decision date: 2004-05-28
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.