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510(k) Data Aggregation
K Number
K955283Device Name
PRIMUS VARIANT SYSTEM PVS99Manufacturer
Date Cleared
1996-03-01
(106 days)
Product Code
Regulation Number
864.7415Type
TraditionalPanel
HematologyReference & Predicate Devices
N/A
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Device Name :
PRIMUS VARIANT SYSTEM PVS99
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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