K Number
K961131Device Name
SALICYLATE ASSAYManufacturer
Date Cleared
1996-04-29
(39 days)
Product Code
Regulation Number
862.3830Type
TraditionalPanel
TXReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 862.3830 Salicylate test system.
(a)
Identification. A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.(b)
Classification. Class II.