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U.S. FDA Medical Device Diluting Pipette Requirements

FDA Medical Device Definition: A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.

Registrar Corp assists Diluting Pipette companies with:

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