MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM

• K Number: K011213
• Device Name: MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
• Manufacturer: BECKMAN COULTER, INC.
• Date Cleared: 2001-05-16 ( 26 days)
• Product Code: JGS CDQ CDT CEK CEM CEO CFJ CGA CGS CGX CGZ CHH CHI CIG CIT CJE CJW CKA CZP DCF DDG DEW DFT DHR DIH DIO DIP DIS DJG DJR DKJ DKZ DLZ DMT GTQ JFJ JFL JFM JFP JGJ JHW JIF JIY JJJ JJO JMO JQB JXM JXN JZJ KLB KLI KLS KLT KXS KXT LCD LCM LCP LDJ LDP LEG LRC MSJ
• Regulation Number: 862.1665

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 862.1665 Sodium test system.

(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.

Summary

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