FIRST CHOICE KETONES URINE TEST STRIPS

• K Number: K953662
• Device Name: FIRST CHOICE KETONES URINE TEST STRIPS
• Manufacturer: POLYMER TECHNOLOGY INTL.
• Date Cleared: 1996-06-14 ( 312 days)
• Product Code: JIN
• Regulation Number: 862.1435

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

§ 862.1435 Ketones (nonquantitative) test system.

(a)
Identification. A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.(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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