Clearance Summary
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 received FDA 510(k) clearance under submission number K093458, sponsored by Beckman Coulter, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2009-12-04.
- Submission: K093458
- Applicant / Sponsor: Beckman Coulter, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1225
- Decision date: 2009-12-04
Classification & Regulation
This clearance is catalogued under FDA product code JFY and 21 CFR 862.1225, within the Clinical Chemistry review panel as a Class II device.