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510(k) Data Aggregation
K Number
K964675Device Name
H.PYLORI CONTROLSManufacturer
Date Cleared
1997-01-27
(67 days)
Product Code
Regulation Number
866.3110Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
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Device Name :
H.PYLORI CONTROLS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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