Clearance Summary
TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE received FDA 510(k) clearance under submission number K851148, sponsored by Euro-Diagnostics BV. 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 1985-04-29.
- Submission: K851148
- Applicant / Sponsor: Euro-Diagnostics BV
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1690
- Decision date: 1985-04-29
Classification & Regulation
This clearance is catalogued under FDA product code JLW and 21 CFR 862.1690, within the Clinical Chemistry review panel as a Class II device.