PSM · Refractometer For Donor Testing
Clinical Chemistry · 21 CFR 862.2800 · Class 1
Overview
| Product Code | PSM |
|---|---|
| Device Name | Refractometer For Donor Testing |
| Regulation | 21 CFR 862.2800 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
