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510(k) Data Aggregation
K Number
K954977Manufacturer
Date Cleared
1996-03-11
(147 days)
Regulation Number
862.2800Type
TraditionalReference & Predicate Devices
N/A
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Product Code :
JRE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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