ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS

• K Number: K000900
• Device Name: ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
• Manufacturer: ELAN HOLDINGS, INC.
• Date Cleared: 2000-05-02 ( 42 days)
• Product Code: CHH
• Regulation Number: 862.1175

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

§ 862.1175 Cholesterol (total) test system.

(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Summary

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