Refractometer For Clinical Use
FDA product code JRE · Class I (low risk) · 21 CFR 862.2800 · Clinical Chemistry
13510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954977 | Urine Reagents STRIPS-8 Parameters (Modification)JRE · Traditional | Teco Diagnostics | 03/11/1996SE |
| K941906 | Model 2730 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 01/17/1995SE |
| K941903 | Model 2740 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 01/17/1995SE |
| K941901 | Model 2721 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 01/17/1995SE |
| K941905 | Model 3461 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 12/13/1994SE |
| K941904 | Model A300CL Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 12/13/1994SE |
| K941902 | Model 3471 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 12/13/1994SE |
| K891681 | Dilectron Urinary Conductivity ProbeJRE · Traditional | Gyrus Medical , Ltd. | 05/01/1990SE |
| K842168 | Atago Urine Specific Gravity & SerumJRE · Traditional | Kyoto Diagnostics, Inc. | 07/16/1984SE |
| K831213 | Specific Gravity InstrumentJRE · Traditional | Iris | 06/30/1983SE |
| K811342 | Reagent Strips for UrinalysisJRE · Traditional | Miles Laboratories, Inc. | 09/01/1981SE |
| K802959 | Nikon Urine Refractomer SG-1JRE · Traditional | Nippon Kogaku, Inc. | 12/19/1980SE |
| K790862 | Biovation Digital UrinometerJRE · Traditional | Biovation, Inc. | 06/28/1979SE |