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U.S. FDA Medical Device Copper Sulfate Solution Requirements


FDA Medical Device Definition: A copper sulfate solution for specific gravity determinations is a device used to determine whether the hemoglobin content of a potential donor's blood meets the required level (12.5 grams per 100 milliliters of blood for women and 13.5 grams per 100 milliliters of blood for men).

Registrar Corp assists Copper Sulfate Solution companies with:

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