SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298— 510(k) K091742

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K091742 for SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298, Substantially Equivalent on 2009-08-14. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JFY
Advisory panel: Clinical Chemistry
Date received: 2009-06-16
Decision date: 2009-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.