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U.S. FDA Medical Device Phospholipids Chromatographic Requirements


FDA Medical Device Definition: A phospholipid test system is a device intended to measure phospholipids in serum and plasma. Measurements of phospholipids are used in the diagnosis and treatment of disorders involving lipid (fat) metabolism.

Registrar Corp assists Phospholipids Chromatographic companies with:

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