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510(k) Data Aggregation
K Number
K955224Device Name
SAS SPICER-EDWARDS 2 ANTISERUMManufacturer
Date Cleared
1996-02-13
(91 days)
Product Code
Regulation Number
866.3550Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
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Device Name :
SAS SPICER-EDWARDS 2 ANTISERUM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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