DeviceClearance

SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298— 510(k) K093458

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K093458 for SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298, Substantially Equivalent on 2009-12-04. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant
Beckman Coulter, Inc.
Product code
Code JFY
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Brea, CA, US
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