ALLIANCE 2690 SEPARATIONS MODULE

• K Number: K961557
• Device Name: ALLIANCE 2690 SEPARATIONS MODULE
• Manufacturer: WATERS CORPORATION
• Date Cleared: 1996-07-05 ( 74 days)
• Product Code: LDM
• Regulation Number: 862.2260

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

§ 862.2260 High pressure liquid chromatography system for clinical use.

(a)
Identification. A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.(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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