Clearance Summary
CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM received FDA 510(k) clearance under submission number K884227, 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 1988-12-09.
- Submission: K884227
- Applicant / Sponsor: A-Kem, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 1988-12-09
Classification & Regulation
This clearance is catalogued under FDA product code JIX and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.