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510(k) K082251

SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 by Beckman Coulter, Inc. — Product Code DCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2009
Date Received
August 8, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Albumin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5040
Review Panel
IM
Submission Type

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