Clearance Summary
TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS received FDA 510(k) clearance under submission number K884224, 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 1988-12-15.
- Submission: K884224
- Applicant / Sponsor: A-Kem, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1110
- Decision date: 1988-12-15
Classification & Regulation
This clearance is catalogued under FDA product code CIG and 21 CFR 862.1110, within the Clinical Chemistry review panel as a Class II device.