Clearance Summary
KINETIC ALKALINE PHOSPHATASE REAGENT KIT received FDA 510(k) clearance under submission number K861638, 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 1986-05-29.
- Submission: K861638
- Applicant / Sponsor: Bio-Analytics Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1050
- Decision date: 1986-05-29
Classification & Regulation
This clearance is catalogued under FDA product code CJE and 21 CFR 862.1050, within the Clinical Chemistry review panel as a Class II device.