JRE
13 FDA 510(k) clearances · Product code
238 daysmedian time to decision
273 days90th percentile
13clearances measured
FDA profile
- Official device name
- Refractometer For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2800
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) (K954977) | Teco Diagnostics | 1996-03-11 |
| MODEL 2721 CLINICAL REFRACTOMETER (K941901) | Vee Gee Scientific, Inc. | 1995-01-17 |
| MODEL 2730 CLINICAL REFRACTOMETER (K941906) | Vee Gee Scientific, Inc. | 1995-01-17 |
| MODEL 2740 CLINICAL REFRACTOMETER (K941903) | Vee Gee Scientific, Inc. | 1995-01-17 |
| MODEL 3461 CLINICAL REFRACTOMETER (K941905) | Vee Gee Scientific, Inc. | 1994-12-13 |
| MODEL 3471 CLINICAL REFRACTOMETER (K941902) | Vee Gee Scientific, Inc. | 1994-12-13 |
| MODEL A300CL CLINICAL REFRACTOMETER (K941904) | Vee Gee Scientific, Inc. | 1994-12-13 |
| DILECTRON URINARY CONDUCTIVITY PROBE (K891681) | Gyrus Medical , Ltd. | 1990-05-01 |
| ATAGO URINE SPECIFIC GRAVITY & SERUM (K842168) | Kyoto Diagnostics, Inc. | 1984-07-16 |
| SPECIFIC GRAVITY INSTRUMENT (K831213) | Iris | 1983-06-30 |
| REAGENT STRIPS FOR URINALYSIS (K811342) | Miles Laboratories, Inc. | 1981-09-01 |
| NIKON URINE REFRACTOMER SG-1 (K802959) | Nippon Kogaku, Inc. | 1980-12-19 |
| BIOVATION DIGITAL URINOMETER (K790862) | Biovation, Inc. | 1979-06-28 |
Track JRE automatically
Every clearance here is in the API, with alerts when new ones post.