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U.S. FDA Medical Device Microtome & Accessories Requirements

FDA Medical Device Definition: Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

Registrar Corp assists Microtome & Accessories companies with:

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