Clearance Summary
DCL MICROALBUMIN ASSAY, MODEL 252-20 received FDA 510(k) clearance under submission number K051191, sponsored by Diagnostic Chemicals , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2005-07-05.
- Submission: K051191
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5040
- Decision date: 2005-07-05
Classification & Regulation
This clearance is catalogued under FDA product code DCF and 21 CFR 866.5040, within the Immunology review panel as a Class II device.