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510(k) Data Aggregation
K Number
K072189Device Name
PATHFAST NTPROBNP AND D-DIMER TESTSManufacturer
Date Cleared
2008-02-05
(183 days)
Product Code
Regulation Number
862.1117Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
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Device Name :
PATHFAST NTPROBNP AND D-DIMER TESTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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