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U.S. FDA Medical Device Clinical Sample Concentrator Requirements


FDA Medical Device Definition: A clinical sample concentrator is a device intended to concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid, and other body fluids before the fluids are analyzed.

Registrar Corp assists Clinical Sample Concentrator companies with:

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