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


FDA Medical Device Definition: A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

Registrar Corp assists Lactic Acid Test System companies with:

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