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U.S. FDA Medical Device Osmometer Requirements

FDA Medical Device Definition: An osmometer for clinical use is a device intended to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent the passage of a solution with a lesser solute concentration into a solution with greater solute concentration when the two solutions are separated by a semipermeable membrane. The concentration of a solution affects its osmotic pressure, freezing point, and other physiochemical properties. Osmometers determine osmotic pressure by methods such as the measurement of the freezing point. Measurements obtained by this device are used in the diagnosis and treatment of body fluid disorders.

Registrar Corp assists Osmometer companies with:

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