GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM

• K Number: K962687
• Device Name: GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM
• Manufacturer: NICHOLS INSTITUTE DIAGNOSTICS
• Date Cleared: 1997-03-28 ( 260 days)
• Product Code: JQW
• Regulation Number: 862.2750

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

§ 862.2750 Pipetting and diluting system for clinical use.

(a)
Identification. A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.(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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