SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607— 510(k) K091846

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K091846 for SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607, Substantially Equivalent on 2009-10-16. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 2009-06-22
Decision date: 2009-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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