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U.S. Department of Health and Human Services

Product Classification

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Device calibrator, dose, radionuclide
Regulation Description Radionuclide dose calibrator.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeKPT
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1360
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Guidance for the Submission of Premarket Notifications for Radionuclide Dose Calibrators; Final
Third Party Review
Accredited Persons

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