Clearance Summary
DEXPAD, BLOOD GLUCOSE STRIP received FDA 510(k) clearance under submission number K880585, sponsored by Mach Diag. C/O Wichita State University. 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 1988-04-18.
- Submission: K880585
- Applicant / Sponsor: Mach Diag. C/O Wichita State University
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 1988-04-18
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.