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U.S. FDA Medical Device Automated Heparin Analyzer Requirements: Automated Heparin Analyzer

FDA Medical Device Definition: An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation

Registrar Corp assists Automated Heparin Analyzer companies with:

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