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U.S. FDA Medical Device Coagulation Instrument Requirements: Coagulation Instrument

FDA Medical Device Definition: A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies

Registrar Corp assists Coagulation Instrument companies with:

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




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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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