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.
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.
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