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U.S. FDA Medical Device Automated Slide Spinner Requirements


FDA Medical Device Definition: An automated slide spinner is a device that prepares automatically a blood film on a microscope slide using a small amount of peripheral blood (blood circulating in one of the body's extremities, such as the arm).

Registrar Corp assists Automated Slide Spinner companies with:

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