Clearance Summary
CREATININE-S ASSAY received FDA 510(k) clearance under submission number K934587, 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 1994-03-11.
- Submission: K934587
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1225
- Decision date: 1994-03-11
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.