K Number
K010812Device Name
EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229Manufacturer
Date Cleared
2001-04-13
(25 days)
Product Code
Regulation Number
862.3320Type
SpecialPanel
CHReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.