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U.S. FDA Medical Device pH Meter 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 pH Meter companies with:

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