SPECIFIC GRAVITY INSTRUMENT
Device Facts
| Record ID | K831213 |
|---|---|
| Device Name | SPECIFIC GRAVITY INSTRUMENT |
| Applicant | Iris |
| Product Code | JRE · Clinical Chemistry |
| Decision Date | Jun 30, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2800 |
| Device Class | Class 1 |
Regulatory Classification
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.
