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.
FDA Polarimeter Detentions (Polarimeter Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Polarimeter Manufacturers (Polarimeter Suppliers)
- Polarimeter Distributors
- Polarimeter Processors
- Polarimeter Repackers
- Polarimeter Relabelers
- Polarimeter Exporters
- Polarimeter Importers
For more information about Polarimeter 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.