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510(k) Data Aggregation
K Number
K961317Device Name
SYPHILIS IGM HUMAN SERUM CONTROLSManufacturer
Date Cleared
1996-06-24
(80 days)
Product Code
Regulation Number
866.3830Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
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Device Name :
SYPHILIS IGM HUMAN SERUM CONTROLS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
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