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510(k) Data Aggregation
K Number
K010878Manufacturer
Date Cleared
2001-04-18
(30 days)
Product Code
Regulation Number
866.3305Type
SpecialPanel
MicrobiologyReference & Predicate Devices
N/A
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Device Name :
MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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