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510(k) Data Aggregation
K Number
K001679Manufacturer
Date Cleared
2000-06-28
(27 days)
Regulation Number
862.1100Type
SpecialPanel
Clinical ChemistryReference & Predicate Devices
N/A
Why did this record match?
Device Name :
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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