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U.S. FDA Medical Device Ultra Microtome Requirements

FDA Medical Device Definition: Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides

Registrar Corp assists Ultra Microtome companies with:

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