Clearance Summary
CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 received FDA 510(k) clearance under submission number K000055, sponsored by Diagnostic Chemicals , Ltd.. 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 2000-02-18.
- Submission: K000055
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1225
- Decision date: 2000-02-18
Classification & Regulation
This clearance is catalogued under FDA product code CGX and 21 CFR 862.1225, within the Clinical Chemistry review panel as a Class II device.