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U.S. Department of Health and Human Services

Product Classification

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Device calibrators, drug specific
Regulation Description Clinical toxicology calibrator.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeDLJ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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] 
Third Party Review
Accredited Persons

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