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510(k) Data Aggregation
K Number
K061347Device Name
VITEK 2 GRAM POSITIVE VRSA SCREENManufacturer
Date Cleared
2006-06-20
(36 days)
Product Code
Regulation Number
866.1645Type
TraditionalPanel
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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