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U.S. FDA Medical Device Plasma Oncometer Requirements

FDA Medical Device Definition: A plasma oncometer for clinical use is a device intended to measure plasma oncotic pressure, which is that portion of the total plasma osmotic pressure contributed by protein and other molecules too large to pass through a specified semipermeable membrane. Because variations in plasma oncotic pressure are indications of certain disorders, measurements of the variations are useful in the diagnosis and treatment of these disorders.

Registrar Corp assists Plasma Oncometer companies with:

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