DeviceClearance

DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR— 510(k) K053090

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K053090 for DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR, Substantially Equivalent on 2005-12-16. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant
Beckman Coulter, Inc.
Product code
Code JFM
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brea, CA, US
Download summary PDFView on FDA.gov ↗

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