Clearance Summary
HEMOTECT received FDA 510(k) clearance under submission number K822731, sponsored by Bio-Chem Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1982-10-18.
- Submission: K822731
- Applicant / Sponsor: Bio-Chem Laboratories
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6550
- Decision date: 1982-10-18
Classification & Regulation
This clearance is catalogued under FDA product code KHE and 21 CFR 864.6550, within the Hematology review panel as a Class II device.