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K Number
K011465
Device Name
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
Manufacturer
BECKMAN COULTER, INC.
Date Cleared
2001-06-08

(25 days)

Product Code
LDP,CDQ,CDT,CEK,CEM,CFJ,CFR,CGA,CGS,CGX,CGZ,CHH,CHI,CHW,CIG,CIT,CJE,CJW,CJY,CKA,CZP,DCF,DCK,DDG,DDT,DEW,DFT,DHR,DIO,DIP,DIS,DJG,DJR,DKJ,DKZ,DLZ,DMT,GTQ,JFJ,JFL,JFM,JFP,JGG,JGS,JHW,JJE,JMO,JOB,JXM,JXN,JZJ,KHQ,KLI,KLS,KLT,KXS,KXT,LCD,LCM,LCP,LCR,LDJ,LEG
Regulation Number
862.3030
Type
Special
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 862.3030 Acetaminophen test system.

(a)
Identification. An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.(b)
Classification. Class II.