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510(k) Data Aggregation
K Number
K001397Device Name
QUICKSCREEN PRO DRUG CUP, MODEL 9195XManufacturer
Date Cleared
2000-05-26
(23 days)
Regulation Number
862.3100Type
SpecialPanel
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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