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U.S. Department of Health and Human Services

Product Classification
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Device calibrators, ethyl alcohol
Regulation Description Clinical toxicology calibrator.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeDNN
Submission Type 510(k)
Regulation Number 862.3200
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092800.htm] 
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