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510(k) Data Aggregation
K Number
K010522Device Name
SUREVUE URINE HCGManufacturer
Date Cleared
2001-07-31
(159 days)
Product Code
Regulation Number
862.1155Type
TraditionalPanel
ToxicologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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