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U.S. FDA Medical Device Environmental Chamber Requirements


FDA Medical Device Definition: An environmental chamber for storage of platelet concentrate is a device used to hold platelet-rich plasma within a preselected temperature range.

Registrar Corp assists Environmental Chamber companies with:

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