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

FDA Medical Device Definition: A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes

Registrar Corp assists Creatinine Test System companies with:

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