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510(k) Data Aggregation
K Number
K955644Device Name
SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEMManufacturer
Date Cleared
1996-02-16
(66 days)
Regulation Number
862.3645Type
TraditionalPanel
ImmunologyReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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