FDA Product Code
FDA Product Code JRE — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2800
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K954977 | URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) | Teco Diagnostics | 1996-03-11 | Traditional | PDF ↗ |
| K941906 | MODEL 2730 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K941903 | MODEL 2740 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K941901 | MODEL 2721 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K941905 | MODEL 3461 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | 1994-12-13 | Traditional | PDF ↗ |
| K941902 | MODEL 3471 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | 1994-12-13 | Traditional | PDF ↗ |
| K941904 | MODEL A300CL CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | 1994-12-13 | Traditional | PDF ↗ |
| K891681 | DILECTRON URINARY CONDUCTIVITY PROBE | Gyrus Medical , Ltd. | 1990-05-01 | Traditional | PDF ↗ |
| K842168 | ATAGO URINE SPECIFIC GRAVITY & SERUM | Kyoto Diagnostics, Inc. | 1984-07-16 | Traditional | PDF ↗ |
| K831213 | SPECIFIC GRAVITY INSTRUMENT | Iris | 1983-06-30 | Traditional | PDF ↗ |
| K811342 | REAGENT STRIPS FOR URINALYSIS | Miles Laboratories, Inc. | 1981-09-01 | Traditional | PDF ↗ |
| K802959 | NIKON URINE REFRACTOMER SG-1 | Nippon Kogaku, Inc. | 1980-12-19 | Traditional | PDF ↗ |
| K790862 | BIOVATION DIGITAL URINOMETER | Biovation, Inc. | 1979-06-28 | Traditional | PDF ↗ |
Product code JRE · Class I · Clinical Chemistry. Data: openFDA.