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510(k) Data Aggregation
K Number
K011306Manufacturer
Date Cleared
2001-05-16
(16 days)
Product Code
Regulation Number
862.3170Type
SpecialPanel
Toxicology (TX)Reference & Predicate Devices
N/A
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Device Name :
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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