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510(k) Data Aggregation
K Number
K000012Device Name
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5Manufacturer
Date Cleared
2000-03-03
(60 days)
Product Code
Regulation Number
862.3660Type
TraditionalPanel
ToxicologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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