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510(k) Data Aggregation
K Number
K961431Device Name
LACTATE DEHYDROGENASE REAGENT SETManufacturer
Date Cleared
1996-06-03
(49 days)
Product Code
Regulation Number
862.1440Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
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Device Name :
LACTATE DEHYDROGENASE REAGENT SET
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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