Clearance Summary
CHEMCARD GLUCOSE TEST received FDA 510(k) clearance under submission number K943503, sponsored by Chem-Elec, 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 1996-07-23.
- Submission: K943503
- Applicant / Sponsor: Chem-Elec, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 1996-07-23
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.