Clearance Summary
STAT-CRIT HEMATOCRIT MEASURING INSTRU received FDA 510(k) clearance under submission number K802199, sponsored by United States Surgical, A Division of Tyco Healthc. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1981-02-04.
- Submission: K802199
- Applicant / Sponsor: United States Surgical, A Division of Tyco Healthc
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5600
- Decision date: 1981-02-04
Classification & Regulation
This clearance is catalogued under FDA product code GKF and 21 CFR 864.5600, within the Hematology review panel as a Class II device.