← Product Code [JRE](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE) · K954977

# URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) (K954977)

_Teco Diagnostics · JRE · Mar 11, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K954977

## Device Facts

- **Applicant:** Teco Diagnostics
- **Product Code:** [JRE](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE.md)
- **Decision Date:** Mar 11, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2800
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K954977](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K954977)

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