Clearance Summary
MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C received FDA 510(k) clearance under submission number K001891, sponsored by Bio/Data Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2000-07-12.
- Submission: K001891
- Applicant / Sponsor: Bio/Data Corp.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5400
- Decision date: 2000-07-12
Classification & Regulation
This clearance is catalogued under FDA product code GKP and 21 CFR 864.5400, within the Hematology review panel as a Class II device.