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510(k) Data Aggregation
K Number
K963005Manufacturer
Date Cleared
1996-08-23
(21 days)
Regulation Number
862.1160Type
TraditionalReference & Predicate Devices
N/A
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Device Name :
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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