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U.S. FDA Medical Device Refractometer Requirements

FDA Medical Device Definition: A refractometer for clinical use is a device intended to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.

Registrar Corp assists Refractometer companies with:

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