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510(k) Data Aggregation
K Number
K011096Device Name
ABBOTT ACCLAIM ENCORE, MODEL 12237Manufacturer
Date Cleared
2001-05-01
(21 days)
Product Code
Regulation Number
880.5725Type
SpecialPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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