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U.S. FDA Medical Device Pyruvic Acid Test System Requirements


FDA Medical Device Definition: A pyruvic acid test system is a device intended to measure pyruvic acid (an intermediate compound in the metabolism of carbohydrate) in plasma. Measurements obtained by this device are used in the evaluation of electrolyte metabolism and in the diagnosis and treatment of acid-base and electrolyte disturbances or anoxia (the reduction of oxygen in body tissues).

Registrar Corp assists Pyruvic Acid Test System companies with:

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