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510(k) Data Aggregation
K Number
K010534Device Name
CROSS-CHECKS DUAL, MODEL CI 125Manufacturer
Date Cleared
2001-08-06
(164 days)
Product Code
Regulation Number
880.2800Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
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Device Name :
CROSS-CHECKS DUAL, MODEL CI 125
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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