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510(k) Data Aggregation
K Number
K000402Manufacturer
Date Cleared
2000-04-18
(71 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
ToxicologyReference & Predicate Devices
N/A
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Device Name :
SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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