Clearance Summary
EMC-M-180, T3 UPTAKE - 100 TUBES received FDA 510(k) clearance under submission number K800188, 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: K800188
- Applicant / Sponsor: Endocrine-Metabolic Center
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1715
- Decision date: 1980-02-13
Classification & Regulation
This clearance is catalogued under FDA product code KHQ and 21 CFR 862.1715, within the Clinical Chemistry review panel as a Class II device.