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U.S. FDA Medical Device TLC Atomizer 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 Atomizer companies with:

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