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U.S. FDA Medical Device Micro Chemistry Analyzer Requirements


FDA Medical Device Definition: A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

Registrar Corp assists Micro Chemistry Analyzer companies with:

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