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U.S. FDA Medical Device TLC Alumina 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 Alumina Plate companies with:

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