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510(k) Data Aggregation
K Number
K000155Manufacturer
Date Cleared
2000-05-17
(119 days)
Product Code
Regulation Number
866.5870Type
TraditionalPanel
ImmunologyReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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