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510(k) Data Aggregation
K Number
K000829Device Name
GATIFLOXACIN, 5 UG, BBL SENSI-DISCDate Cleared
2000-04-13
(30 days)
Product Code
Regulation Number
866.1620Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
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Device Name :
GATIFLOXACIN, 5 UG, BBL SENSI-DISC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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