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.
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.
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