PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM

• K Number: K953077
• Device Name: PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM
• Manufacturer: BECKMAN INSTRUMENTS, INC.
• Date Cleared: 1996-01-05 ( 189 days)
• Product Code: CDF CFF JQT
• Regulation Number: 862.1795

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

§ 862.1795 Vanilmandelic acid test system.

(a)
Identification. A vanilmandelic acid test system is a device intended to measure vanilmandelic acid in urine. Measurements of vanilmandelic acid obtained by this device are used in the diagnosis and treatment of neuroblastoma, pheochromocytoma, and certain hypertensive conditions.(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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