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U.S. FDA Medical Device Spectacle Dissociation Test Requirements


FDA Medical Device Definition: A spectacle dissociation test system is an AC-powered or battery-powered device, such as a Lancaster test system, that consists of a light source and various filters, usually red or green filters, intended to subjectively measure imbalance of ocular muscles.

Registrar Corp assists Spectacle Dissociation Test companies with:

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