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510(k) Data Aggregation
K Number
K010892Manufacturer
Date Cleared
2001-09-24
(182 days)
Product Code
Regulation Number
866.3120Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
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Device Name :
MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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