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U.S. FDA Medical Device Automated Cell-Locating Device Requirements: Automated Cell-Locating Device

FDA Medical Device Definition: An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm

Registrar Corp assists Automated Cell-Locating Device companies with:

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




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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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