Method, Metallic Reduction, Glucose (urinary, Non-quantitative)

Device Code: 439

Product Code(s): JIM

Device Classification Information

• Device Type ID: 439
• Device Name: Method, Metallic Reduction, Glucose (urinary, Non-quantitative)
• Regulation Description: Urinary Glucose (nonquantitative) Test System.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 862.1340 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JIM
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 439
• Device: Method, Metallic Reduction, Glucose (urinary, Non-quantitative)
• Product Code: JIM
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Urinary Glucose (nonquantitative) Test System.
• CFR Regulation Number: 862.1340 [🔎]

TPLC Last Update: 2019-04-02 19:34:40