SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT— 510(k) K013978

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K013978 for SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT, Substantially Equivalent on 2002-01-15. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 2001-12-03
Decision date: 2002-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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