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U.S. FDA Medical Device Phase Contrast Microscope Requirements


FDA Medical Device Definition: Microscopes and accessories are optical instruments used to enlarge images of specimens, preparations, and cultures for medical purposes. Variations of microscopes and accessories (through a change in the light source) used for medical purposes include the following:

Registrar Corp assists Phase Contrast Microscope companies with:

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