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U.S. FDA Medical Device Pipetting & Diluting Station Requirements


FDA Medical Device Definition: A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.

Registrar Corp assists Pipetting & Diluting Station companies with:

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