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510(k) Data Aggregation
K Number
K011303Device Name
RANDOX PHENOBARBITALManufacturer
Date Cleared
2001-07-02
(63 days)
Product Code
Regulation Number
862.3660Type
TraditionalPanel
ToxicologyReference & Predicate Devices
N/A
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Device Name :
RANDOX PHENOBARBITAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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