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510(k) Data Aggregation
K Number
K961538Device Name
SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUMManufacturer
Date Cleared
1996-05-20
(28 days)
Product Code
Regulation Number
866.3660Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
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Device Name :
SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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