Clearance Summary
ANGIOTENSIN CONVERTING ENZYME received FDA 510(k) clearance under submission number K833777, sponsored by Immuno-Diagnostic Laboratories. 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 1984-01-30.
- Submission: K833777
- Applicant / Sponsor: Immuno-Diagnostic Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1085
- Decision date: 1984-01-30
Classification & Regulation
This clearance is catalogued under FDA product code CIB and 21 CFR 862.1085, within the Clinical Chemistry review panel as a Class II device.