Clearance Summary
COAGULATION REFERENCE PLASMA, ABNORMAL received FDA 510(k) clearance under submission number K904073, sponsored by Medi-Tech, 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 1990-10-22.
- Submission: K904073
- Applicant / Sponsor: Medi-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 1990-10-22
Classification & Regulation
This clearance is catalogued under FDA product code GGC and 21 CFR 864.5425, within the Hematology review panel as a Class II device.