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510(k) K014173

SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR by Beckman Coulter, Inc. — Product Code DKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2002
Date Received
December 20, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Salicylate
Device Class
Class II
Regulation Number
862.3830
Review Panel
TX
Submission Type

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