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U.S. FDA Medical Device Color Vision Tester Requirements

FDA Medical Device Definition: A color vision tester is a device that consists of various colored materials, such as colored yarns or color vision plates (multicolored plates which patients with color vision deficiency would perceive as being of one color), intended to evaluate color vision.

Registrar Corp assists Color Vision Tester companies with:

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

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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