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510(k) Data Aggregation
K Number
K003204Manufacturer
Date Cleared
2000-11-07
(25 days)
Product Code
Regulation Number
866.3330Type
SpecialPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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