HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST

• K Number: K954968
• Device Name: HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST
• Manufacturer: TCPI, INC.
• Date Cleared: 1996-07-26 ( 273 days)
• Product Code: JIL
• Regulation Number: 862.1340
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: 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

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.