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U.S. FDA Medical Device TLC Silica Gel 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 Silica Gel Plate companies with:

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