Registrar Corp

HomeMedical DevicesRegistration & Medical Device ListingsMedical Device Samples › U.S. FDA Phenylketones Chromogenesis Regulations

U.S. FDA Medical Device Phenylketones Chromogenesis Requirements


FDA Medical Device Definition: A urinary phenylketones (nonquantitative) test system is a device intended to identify phenylketones (such as phenylpyruvic acid) in urine. The identification of urinary phenylketones is used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.

Registrar Corp assists Phenylketones Chromogenesis companies with:

  • FDA Phenylketones Chromogenesis Establishment Registration
  • FDA Phenylketones Chromogenesis Listing
  • FDA Phenylketones Chromogenesis Label Requirements and Exceptions
  • FDA Phenylketones Chromogenesis Import Information
  • FDA Phenylketones Chromogenesis Detentions (Phenylketones Chromogenesis Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Phenylketones Chromogenesis Manufacturers (Phenylketones Chromogenesis Suppliers)
       - Phenylketones Chromogenesis Distributors
       - Phenylketones Chromogenesis Processors
       - Phenylketones Chromogenesis Repackers
       - Phenylketones Chromogenesis Relabelers
       - Phenylketones Chromogenesis Exporters
       - Phenylketones Chromogenesis Importers
For more information about Phenylketones Chromogenesis 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.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
 
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco