Clearance Summary
BLHI LUTEINIZING HORMONE received FDA 510(k) clearance under submission number K851332, 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 1985-07-09.
- Submission: K851332
- Applicant / Sponsor: Euro-Diagnostics BV
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1485
- Decision date: 1985-07-09
Classification & Regulation
This clearance is catalogued under FDA product code CEP and 21 CFR 862.1485, within the Clinical Chemistry review panel as a Class I device.