Clearance Summary
PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS received FDA 510(k) clearance under submission number K954202, sponsored by Medtronic Hemotec, 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 1996-06-20.
- Submission: K954202
- Applicant / Sponsor: Medtronic Hemotec, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 1996-06-20
Classification & Regulation
This clearance is catalogued under FDA product code JPA and 21 CFR 864.5425, within the Hematology review panel as a Class II device.