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510(k) Data Aggregation
K Number
K003991Device Name
CD-CAL PLUS CALIBRATORManufacturer
Date Cleared
2001-01-16
(21 days)
Regulation Number
864.8150Type
SpecialPanel
HematologyReference & Predicate Devices
N/A
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Device Name :
CD-CAL PLUS CALIBRATOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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