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U.S. FDA Medical Device Calibrator Requirements: Calibrator

FDA Medical Device Definition: A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part

Registrar Corp assists Calibrator companies with:

  • FDA Calibrator Establishment Registration
  • FDA Calibrator Listing
  • FDA Calibrator Label Requirements and Exceptions
  • FDA Calibrator Import Information
  • FDA Calibrator Detentions (Calibrator Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Calibrator Manufacturers (Calibrator Suppliers)
       - Calibrator Distributors
       - Calibrator Processors
       - Calibrator Repackers
       - Calibrator Relabelers
       - Calibrator Exporters
       - Calibrator Importers
For more information about Calibrator Medical Devices, simply click below:

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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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