Clearance Summary
BACI 6 -ADRENOCORTICOTROOP HORMONE received FDA 510(k) clearance under submission number K850053, 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 1985-04-08.
- Submission: K850053
- Applicant / Sponsor: Euro-Diagnostics BV
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1025
- Decision date: 1985-04-08
Classification & Regulation
This clearance is catalogued under FDA product code CKG and 21 CFR 862.1025, within the Clinical Chemistry review panel as a Class II device.