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510(k) K080578

DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA by Siemens Healthcare Diagnostics, Inc. — Product Code NBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2008
Date Received
March 3, 2008
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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