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U.S. FDA Medical Device Automated Urinalysis System Requirements


FDA Medical Device Definition: An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

Registrar Corp assists Automated Urinalysis System companies with:

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