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510(k) Data Aggregation
K Number
K955906Device Name
BOEHRINGER MANNHEIM IGG ASSAYManufacturer
Date Cleared
1996-02-09
(42 days)
Product Code
Regulation Number
866.5510Type
TraditionalPanel
ImmunologyReference & Predicate Devices
N/A
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Device Name :
BOEHRINGER MANNHEIM IGG ASSAY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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