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U.S. Department of Health and Human Services

Product Classification

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Device tetraphenyl borate, colorimetry, potassium
Regulation Description Potassium test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeCEJ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1600
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry In Vitro Diagnostic Potassium Test System; Final [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm093902.htm] 
Third Party Review
Accredited Persons

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