JRE · Refractometer For Clinical Use
Clinical Chemistry · 21 CFR 862.2800 · Class 1
Overview
| Product Code | JRE |
|---|---|
| Device Name | Refractometer For Clinical Use |
| 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 (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K954977 | URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) | Teco Diagnostics | Mar 11, 1996 | SESE |
| K941906 | MODEL 2730 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | Jan 17, 1995 | SESE |
| K941903 | MODEL 2740 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | Jan 17, 1995 | SESE |
| K941901 | MODEL 2721 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | Jan 17, 1995 | SESE |
| K941905 | MODEL 3461 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | Dec 13, 1994 | SESE |
| K941904 | MODEL A300CL CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | Dec 13, 1994 | SESE |
| K941902 | MODEL 3471 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | Dec 13, 1994 | SESE |
| K891681 | DILECTRON URINARY CONDUCTIVITY PROBE | Gyrus Medical , Ltd. | May 1, 1990 | SESE |
| K842168 | ATAGO URINE SPECIFIC GRAVITY & SERUM | Kyoto Diagnostics, Inc. | Jul 16, 1984 | SESE |
| K831213 | SPECIFIC GRAVITY INSTRUMENT | Iris | Jun 30, 1983 | SESE |
| K811342 | REAGENT STRIPS FOR URINALYSIS | Miles Laboratories, Inc. | Sep 1, 1981 | SESE |
| K802959 | NIKON URINE REFRACTOMER SG-1 | Nippon Kogaku, Inc. | Dec 19, 1980 | SESE |
| K790862 | BIOVATION DIGITAL URINOMETER | Biovation, Inc. | Jun 28, 1979 | SESE |
Top Applicants
- Vee Gee Scientific, Inc. — 6 clearances
- Biovation, Inc. — 1 clearance
- Gyrus Medical , Ltd. — 1 clearance
- Iris — 1 clearance
- Kyoto Diagnostics, Inc. — 1 clearance
