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510(k) Data Aggregation
K Number
K002551Device Name
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109ULManufacturer
Date Cleared
2000-10-11
(55 days)
Product Code
Regulation Number
862.3645Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
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Device Name :
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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