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U.S. FDA Medical Device Olfactory Test Kit Requirements

FDA Medical Device Definition: An olfactory test device is used to determine whether an olfactory loss is present. The device includes one or more odorants that are presented to the patient's nose to subjectively assess the patient's ability to perceive odors.

Registrar Corp assists Olfactory Test Kit companies with:

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