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U.S. FDA Medical Device Automated Cell Counter Requirements: Automated Cell Counter

FDA Medical Device Definition: An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method

Registrar Corp assists Automated Cell Counter companies with:

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