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510(k) Data Aggregation
Device Name
CBC-CAL PLUS HEMATOLOGY CALIBRATORManufacturer
Date Cleared
1996-02-29
(69 days)
Regulation Number
864.8150Type
TraditionalPanel
HematologyAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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