Product Classification

• Device: method, metallic reduction, glucose (urinary, non-quantitative)
• Regulation Description: Urinary glucose (nonquantitative) test system.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: JIM
• Submission Type: 510(k)
• Regulation Number: 862.1340
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.