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510(k) K071767

DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A by Dade Behring, Inc. — Product Code NBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2007
Date Received
June 29, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Natriuretic Peptide
Device Class
Class II
Regulation Number
862.1117
Review Panel
CH
Submission Type

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