Clearance Summary
EMC-M-175, THYROXINE - 100 TUBES received FDA 510(k) clearance under submission number K800187, sponsored by Endocrine-Metabolic Center. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1980-02-13.
- Submission: K800187
- Applicant / Sponsor: Endocrine-Metabolic Center
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1700
- Decision date: 1980-02-13
Classification & Regulation
This clearance is catalogued under FDA product code CDX and 21 CFR 862.1700, within the Clinical Chemistry review panel as a Class II device.