K Number
DEN070001Manufacturer
Date Cleared
2018-09-21
(4266 days)
Product Code
Regulation Number
866.3315Type
Post-NSEPanel
MicrobiologyReference & 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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N/A