FDA product code JRE: Refractometer For Clinical Use
JRE is the FDA product code for refractometer for clinical use. It is a Class I device, regulated under 21 CFR 862.2800 and reviewed by the Clinical Chemistry panel. FDA has cleared 13 510(k) submissions under JRE, from 8 different applicants. The average 510(k) review took 185 days (median 238).
Classification
| Field | Value |
|---|---|
| Device name | Refractometer For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2800 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JRE clearance
Top JRE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vee Gee Scientific, Inc. | 6 | 1995-01-17 |
| Teco Diagnostics | 1 | 1996-03-11 |
| Gyrus Medical , Ltd. | 1 | 1990-05-01 |
| Kyoto Diagnostics, Inc. | 1 | 1984-07-16 |
| Iris | 1 | 1983-06-30 |
3 more applicants have JRE clearances. See the full list in Caduvo.
Most recent JRE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K954977 | Teco Diagnostics | URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) | 1996-03-11 | 147 |
| K941906 | Vee Gee Scientific, Inc. | MODEL 2730 CLINICAL REFRACTOMETER | 1995-01-17 | 273 |
| K941901 | Vee Gee Scientific, Inc. | MODEL 2721 CLINICAL REFRACTOMETER | 1995-01-17 | 273 |
| K941903 | Vee Gee Scientific, Inc. | MODEL 2740 CLINICAL REFRACTOMETER | 1995-01-17 | 273 |
| K941905 | Vee Gee Scientific, Inc. | MODEL 3461 CLINICAL REFRACTOMETER | 1994-12-13 | 238 |
Recalls for JRE devices
openFDA lists no recalls for product code JRE.
Frequently asked questions
What is FDA product code JRE?
JRE is the FDA product code for refractometer for clinical use. It is a Class I device, regulated under 21 CFR 862.2800 and reviewed by the Clinical Chemistry panel.
What device class is JRE?
Class I, regulation 21 CFR 862.2800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JRE?
Across 13 cleared submissions the average was 185 days from receipt to decision (median 238).
Which companies have the most JRE clearances?
Vee Gee Scientific, Inc. (6); Teco Diagnostics (1); Gyrus Medical , Ltd. (1); Kyoto Diagnostics, Inc. (1); Iris (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JRE
- Run a recall and safety report across every JRE manufacturer
- Watch product code JRE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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