Clearance Summary
ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT received FDA 510(k) clearance under submission number K810082, 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 1981-01-26.
- Submission: K810082
- 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: 1981-01-26
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.