Clearance Summary
BLOOD PLATELET ASSAY METHOD & APPARATUS received FDA 510(k) clearance under submission number K862302, sponsored by Bellhouse Medical, 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 1986-07-31.
- Submission: K862302
- Applicant / Sponsor: Bellhouse Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5700
- Decision date: 1986-07-31
Classification & Regulation
This clearance is catalogued under FDA product code JOZ and 21 CFR 864.5700, within the Hematology review panel as a Class II device.