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U.S. FDA Medical Device Cryostat 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 Cryostat Microtome companies with:

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