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U.S. Department of Health and Human Services

Product Classification

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Device calibrator, secondary
Regulation Description Calibrator.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeJIT
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1150
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
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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