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U.S. FDA Medical Device Perfusion Apparatus Requirements

FDA Medical Device Definition: Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.

Registrar Corp assists Perfusion Apparatus companies with:

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