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U.S. Department of Health and Human Services

Product Classification

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Device enzymatic method, creatinine
Regulation Description Creatinine test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeJFY
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1225
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 Creatinine Test System; Final [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm093990.htm] 
Third Party Review
Accredited Persons

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