WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX

• K Number: K001934
• Device Name: WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
• Manufacturer: WAKO CHEMICALS, USA, INC.
• Date Cleared: 2000-07-24 ( 28 days)
• Product Code: DFC
• Regulation Number: 866.5600

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

§ 866.5600 Low-density lipoprotein immunological test system.

(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).

Summary

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