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510(k) K013978

SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT by Beckman Coulter, Inc. — Product Code JFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2002
Date Received
December 3, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catalytic Methods, Amylase
Device Class
Class II
Regulation Number
862.1070
Review Panel
CH
Submission Type

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