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U.S. FDA Medical Device TLC Cellulose Plate Requirements

FDA Medical Device Definition: A thin-layer chromatography (TLC) system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. The mixture of compounds is absorbed onto a stationary phase or thin layer of inert material (e.g., cellulose, alumina, etc.) and eluted off by a moving solvent (moving phase) until equilibrium occurs between the two phases.

Registrar Corp assists TLC Cellulose Plate companies with:

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