Clearance Summary
COLORIMETRIC BUN received FDA 510(k) clearance under submission number K831414, sponsored by Bio-Analytics Laboratories, Inc.. 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 1983-06-16.
- Submission: K831414
- Applicant / Sponsor: Bio-Analytics Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1770
- Decision date: 1983-06-16
Classification & Regulation
This clearance is catalogued under FDA product code CDL and 21 CFR 862.1770, within the Clinical Chemistry review panel as a Class II device.