Clearance Summary
PLATELET AGGREGATION PROFILER #PAP-4 received FDA 510(k) clearance under submission number K821005, sponsored by Bio/Data Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1982-06-01.
- Submission: K821005
- Applicant / Sponsor: Bio/Data Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6675
- Decision date: 1982-06-01
Classification & Regulation
This clearance is catalogued under FDA product code JBX and 21 CFR 864.6675, within the Hematology review panel as a Class II device.