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U.S. FDA Medical Device Automated Slide Stainer Requirements


FDA Medical Device Definition: An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

Registrar Corp assists Automated Slide Stainer companies with:

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