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U.S. FDA Medical Device General Laboratory Timer Requirements


FDA Medical Device Definition: General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

Registrar Corp assists General Laboratory Timer companies with:

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