Clearance Summary
A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM received FDA 510(k) clearance under submission number K882587, sponsored by A-Kem, 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 1988-08-08.
- Submission: K882587
- Applicant / Sponsor: A-Kem, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1035
- Decision date: 1988-08-08
Classification & Regulation
This clearance is catalogued under FDA product code CIX and 21 CFR 862.1035, within the Clinical Chemistry review panel as a Class II device.