Clearance Summary
URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C received FDA 510(k) clearance under submission number K880584, 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 1988-05-31.
- Submission: K880584
- Applicant / Sponsor: Mach Diag. C/O Wichita State University
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1785
- Decision date: 1988-05-31
Classification & Regulation
This clearance is catalogued under FDA product code CDM and 21 CFR 862.1785, within the Clinical Chemistry review panel as a Class I device.