Clearance Summary
CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 received FDA 510(k) clearance under submission number K051757, 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 2005-11-10.
- Submission: K051757
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1145
- Decision date: 2005-11-10
Classification & Regulation
This clearance is catalogued under FDA product code CJY and 21 CFR 862.1145, within the Clinical Chemistry review panel as a Class II device.