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U.S. FDA Medical Device Analytical Balance 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 Analytical Balance companies with:

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