Clearance Summary
GLUCOSE REAGENT KIT received FDA 510(k) clearance under submission number K873128, 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 1987-10-23.
- Submission: K873128
- Applicant / Sponsor: A-Kem, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 1987-10-23
Classification & Regulation
This clearance is catalogued under FDA product code CGA and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.