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U.S. FDA Medical Device Flask Spinner 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 Flask Spinner companies with:

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