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510(k) Data Aggregation
K Number
K000459Manufacturer
Date Cleared
2000-04-03
(52 days)
Product Code
Regulation Number
862.3150Type
TraditionalPanel
ToxicologyReference & Predicate Devices
N/A
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Device Name :
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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