4 results
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16ms
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Sources: EU EUDAMED, US FDA
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
FDA Enforcement
Class II
·Completed·Abbott Molecular, Inc.·August 24, 2022
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
FDA Enforcement
Class II
·Completed·Abbott Laboratories, Inc·November 29, 2017
Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
FDA Enforcement
Class II
·Completed·Abbott Laboratories, Inc·November 29, 2017
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
FDA Enforcement
Class II
·Completed·Abbott Diabetes Care, Inc.·January 24, 2024