SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO

• 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: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: K042270

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 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.