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510(k) K090588

POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 by Beckman Coulter, Inc. — Product Code CDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2009
Date Received
March 4, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Vitamin B12
Device Class
Class II
Regulation Number
862.1810
Review Panel
CH
Submission Type

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