Clearance Summary
CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) received FDA 510(k) clearance under submission number K873625, sponsored by Boots-Celltech Diagnostics, 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 1987-10-20.
- Submission: K873625
- Applicant / Sponsor: Boots-Celltech Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7360
- Decision date: 1987-10-20
Classification & Regulation
This clearance is catalogued under FDA product code JLM and 21 CFR 864.7360, within the Hematology review panel as a Class II device.