Registrar Corp

HomeMedical Devices510(k) Administrative ReviewMedical Device 510(k) Examples › U.S. FDA Clinical Toxicology Calibrator Regulations

U.S. FDA Medical Device Clinical Toxicology Calibrator Requirements: Clinical Toxicology Calibrator

FDA Medical Device Definition: A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also 862.2 in this part

Registrar Corp assists Clinical Toxicology Calibrator companies with:

  • FDA Clinical Toxicology Calibrator Establishment Registration
  • FDA Clinical Toxicology Calibrator Listing
  • FDA Clinical Toxicology Calibrator Label Requirements and Exceptions
  • FDA Clinical Toxicology Calibrator Import Information
  • FDA Clinical Toxicology Calibrator Detentions (Clinical Toxicology Calibrator Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Clinical Toxicology Calibrator Manufacturers (Clinical Toxicology Calibrator Suppliers)
       - Clinical Toxicology Calibrator Distributors
       - Clinical Toxicology Calibrator Processors
       - Clinical Toxicology Calibrator Repackers
       - Clinical Toxicology Calibrator Relabelers
       - Clinical Toxicology Calibrator Exporters
       - Clinical Toxicology Calibrator Importers
For more information about Clinical Toxicology Calibrator Medical Devices, simply click below:




Live Help

 
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