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510(k) Data Aggregation
K Number
K001649Manufacturer
Date Cleared
2000-06-23
(24 days)
Product Code
Regulation Number
880.2800Type
AbbreviatedPanel
General HospitalReference & 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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