Clearance Summary
CRITSPIN MICRO-HEMATOCRIT received FDA 510(k) clearance under submission number K920759, sponsored by Stat-Spin Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1992-04-29.
- Submission: K920759
- Applicant / Sponsor: Stat-Spin Technologies
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6400
- Decision date: 1992-04-29
Classification & Regulation
This clearance is catalogued under FDA product code GKG and 21 CFR 864.6400, within the Hematology review panel as a Class II device.