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510(k) Data Aggregation
K Number
K001547Manufacturer
Date Cleared
2000-08-07
(81 days)
Product Code
Regulation Number
866.1640Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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