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U.S. FDA Medical Device Microscope Lamps 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 Lamps companies with:

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