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U.S. FDA Medical Device Hemocytometer Requirements

FDA Medical Device Definition: A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.

Registrar Corp assists Hemocytometer companies with:

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