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510(k) Data Aggregation
K Number
K954437Device Name
THROMBELASTOGRAPH COAGULATION ANALYZER 3000SManufacturer
Date Cleared
1996-01-30
(130 days)
Product Code
Regulation Number
864.5400Type
TraditionalPanel
HematologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
THROMBELASTOGRAPH COAGULATION ANALYZER 3000S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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