FIRST CHOICE GLUCOSE URINE TEST STRIPS

• K Number: K953661
• Device Name: FIRST CHOICE GLUCOSE URINE TEST STRIPS
• Manufacturer: POLYMER TECHNOLOGY INTL.
• Date Cleared: 1996-06-14 ( 312 days)
• Product Code: JIL
• Regulation Number: 862.1340
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Summary

Loading...

Regulation Number and Section

§ 862.1340 Urinary glucose (nonquantitative) test system.

(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.