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U.S. Department of Health and Human Services

Product Classification
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Device method, enzymatic, glucose (urinary, non-quantitative)
Regulation Description Urinary glucose (nonquantitative) test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeJIL
Submission Type 510(k)
Regulation Number 862.1340
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Guidance for Industry In Vitro Diagnostic Glucose Test System; Final [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm093977.htm] 
Third Party Review
Accredited Persons

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