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U.S. FDA Medical Device Microscope Light 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:(1) Phase contrast microscopes, which permit visualization of unstained preparations by altering the phase relationship of light that passes around the object and through the object.

Registrar Corp assists Microscope Light companies with:

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