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510(k) Data Aggregation
K Number
K965190Manufacturer
Date Cleared
1997-03-19
(85 days)
Product Code
Regulation Number
866.1640Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
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Device Name :
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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