Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device electrode, ion based, enzymatic, creatinine
Regulation Description Creatinine test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeCGL
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

-
-