U.S. FDA Medical Device Refractometer Requirements
FDA Medical Device Definition: A refractometer for clinical use is a device intended to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.
FDA Refractometer Label Requirements and Exceptions
FDA Refractometer Import Information
FDA Refractometer Detentions (Refractometer Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Refractometer Manufacturers (Refractometer Suppliers)
- Refractometer Distributors
- Refractometer Processors
- Refractometer Repackers
- Refractometer Relabelers
- Refractometer Exporters
- Refractometer Importers
For more information about Refractometer Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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