WAKO AUTOKIT LP(A)/ RA,500/1000,

• K Number: K001920
• Device Name: WAKO AUTOKIT LP(A)/ RA,500/1000,
• Manufacturer: WAKO CHEMICALS, USA, INC.
• Date Cleared: 2000-07-23 ( 30 days)
• Product Code: DFC
• Regulation Number: 866.5600
• Type: Special
• Panel: IM
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML 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).