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510(k) Data Aggregation
K Number
K954986Device Name
GC BASE W/ 1% GCHIManufacturer
Date Cleared
1996-02-16
(108 days)
Product Code
Regulation Number
866.2410Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
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Device Name :
GC BASE W/ 1% GCHI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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