Registrar Corp

HomeMedical DevicesRegistration & Medical Device ListingsMedical Device Samples › U.S. FDA Pyruvate Kinase Test System Regulations

U.S. FDA Medical Device Pyruvate Kinase Test System Requirements


FDA Medical Device Definition: A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells). Measurements obtained by this device are used in the diagnosis and treatment of various inherited anemias due to pyruvate kinase deficiency or of acute leukemias.

Registrar Corp assists Pyruvate Kinase Test System companies with:

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