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510(k) Data Aggregation
K Number
K002457Device Name
!NSURE FECAL OCCULT BLOOD TESTManufacturer
Date Cleared
2001-01-12
(155 days)
Product Code
Regulation Number
864.6550Type
TraditionalPanel
HematologyReference & Predicate Devices
N/A
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Device Name :
NSURE FECAL OCCULT BLOOD TEST
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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