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510(k) Data Aggregation
K Number
K001067Device Name
DADE BEHRING COAGULATION ANALYZER (BCT)Manufacturer
Date Cleared
2000-06-20
(78 days)
Product Code
Regulation Number
864.5425Type
TraditionalPanel
HematologyReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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