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U.S. FDA Medical Device Chloride Test System Requirements: Chloride Test System

FDA Medical Device Definition: A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis

Registrar Corp assists Chloride Test System companies with:

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