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510(k) Data Aggregation
K Number
K003012Device Name
RAICHEM PHOSPORUS REAGENTManufacturer
Date Cleared
2000-10-25
(29 days)
Product Code
Regulation Number
862.1580Type
SpecialPanel
Clinical ChemistryReference & Predicate Devices
N/A
Why did this record match?
Device Name :
RAICHEM PHOSPORUS REAGENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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