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510(k) Data Aggregation
K Number
K170940Device Name
Rickettsia Real-time PCR AssayManufacturer
Date Cleared
2017-06-29
(91 days)
Product Code
Regulation Number
866.3316Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
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Product Code :
PVQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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