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U.S. FDA Medical Device Chromatography(Gas) Requirements

FDA Medical Device Definition: A gas liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. Each of the constituents in a vaporized mixture of compounds is separated according to its vapor pressure. The device may include accessories such as columns, gases, column supports, and liquid coating.

Registrar Corp assists Chromatography(Gas) companies with:

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