Clearance Summary
ENZYMATIC ALPHA-AMYLASE REAGENT KIT received FDA 510(k) clearance under submission number K850639, 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 1985-03-05.
- Submission: K850639
- Applicant / Sponsor: Bio-Analytics Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1070
- Decision date: 1985-03-05
Classification & Regulation
This clearance is catalogued under FDA product code CIW and 21 CFR 862.1070, within the Clinical Chemistry review panel as a Class II device.