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U.S. FDA Medical Device Ion-Exchange Chromatography Requirements


FDA Medical Device Definition: A chromatographic separation material for clinical use is a device accessory (e.g., ion exchange absorbents, ion exchagne resins, and ion papers) intended for use in ion exchange chromatography, a procedure in which a compound is separated from a solution.

Registrar Corp assists Ion-Exchange Chromatography companies with:

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