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U.S. FDA Medical Device Automated Tissue Processor Requirements


FDA Medical Device Definition: An automated tissue processor is an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.

Registrar Corp assists Automated Tissue Processor companies with:

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