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U.S. FDA Medical Device Anaerobic Glove Box Requirements


FDA Medical Device Definition: An anaerobic chamber is a device intended for medical purposes to maintain an anaerobic (oxygen free) environment. It is used to isolate and cultivate anaerobic microorganisms.

Registrar Corp assists Anaerobic Glove Box companies with:

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