URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)

• K Number: K954977
• Device Name: URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)
• Manufacturer: TECO DIAGNOSTICS
• Date Cleared: 1996-03-11 ( 147 days)
• Product Code: JRE CDM JIO JJB JMT
• Regulation Number: 862.2800

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

§ 862.2800 Refractometer for clinical use.

(a)
Identification. A refractometer for clinical use is a device intended to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain 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 the limitations in § 862.9.

Summary

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