Clearance Summary
CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 received FDA 510(k) clearance under submission number K060140, 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 2006-04-24.
- Submission: K060140
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 2006-04-24
Classification & Regulation
This clearance is catalogued under FDA product code JIT and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.