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510(k) K082645

DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 by Siemens Healthcare Diagnostics — Product Code NBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2008
Date Received
September 11, 2008
Clearance Type
Special
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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