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510(k) Data Aggregation
K Number
K954898Device Name
PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)Manufacturer
Date Cleared
1996-02-05
(138 days)
Product Code
Regulation Number
864.7250Type
TraditionalPanel
HematologyReference & Predicate Devices
N/A
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Device Name :
PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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