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U.S. FDA Medical Device Cytocentrifuge Requirements

FDA Medical Device Definition: A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g., cerebrospinal fluid) and to deposit these cells on a glass microscope slide for cytological examination.

Registrar Corp assists Cytocentrifuge companies with:

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