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510(k) Data Aggregation
K Number
K011389Manufacturer
Date Cleared
2001-06-21
(45 days)
Product Code
Regulation Number
864.7415Type
TraditionalPanel
HematologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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