FDA product code JRI: Cuvette, Thermostated
JRI is the FDA product code for cuvette, thermostated. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under JRI, from 4 different applicants. The average 510(k) review took 50 days (median 45).
Classification
| Field | Value |
|---|---|
| Device name | Cuvette, Thermostated |
| Device class | Class I |
| Regulation | 21 CFR 862.2050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every JRI clearance
Top JRI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medatron, Inc. | 1 | 1987-12-14 |
| Gilford Instrument Laboratories, Inc. | 1 | 1978-06-28 |
| The Perkin-Elmer Corp. | 1 | 1976-11-30 |
| Coulter Electronics, Inc. | 1 | 1976-07-19 |
Most recent JRI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873656 | Medatron, Inc. | MEDATRON CUVETTE DISC | 1987-12-14 | 95 |
| K780888 | Gilford Instrument Laboratories, Inc. | THERMO SET ELECTRONIC TEM. CONTROLLER | 1978-06-28 | 33 |
| K760769 | The Perkin-Elmer Corp. | TEMPERATURE REGULATED FIVE CELL HOLDERS | 1976-11-30 | 57 |
| K760197 | Coulter Electronics, Inc. | ACCUVETTE II | 1976-07-19 | 13 |
Recalls for JRI devices
openFDA lists no recalls for product code JRI.
Frequently asked questions
What is FDA product code JRI?
JRI is the FDA product code for cuvette, thermostated. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JRI?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JRI?
Across 4 cleared submissions the average was 50 days from receipt to decision (median 45).
Which companies have the most JRI clearances?
Medatron, Inc. (1); Gilford Instrument Laboratories, Inc. (1); The Perkin-Elmer Corp. (1); Coulter Electronics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JRI
- Run a recall and safety report across every JRI manufacturer
- Watch product code JRI 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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