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U.S. FDA Medical Device Chromatography (Liquid, Gel) Requirements

FDA Medical Device Definition: A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.

Registrar Corp assists Chromatography (Liquid, Gel) companies with:

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