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510(k) Data Aggregation
K Number
K001993Device Name
SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONSManufacturer
Date Cleared
2000-11-13
(137 days)
Product Code
Regulation Number
862.1345Type
TraditionalPanel
Clinical ChemistryReference & 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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