FDA product code JRJ: Unit, Drying
JRJ is the FDA product code for unit, drying. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JRJ. The average 510(k) review took 42 days (median 42). FDA has posted 3 recalls for JRJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Drying |
| 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 JRJ clearance
Top JRJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Instruments, Inc. | 1 | 1979-07-24 |
Most recent JRJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K791077 | Beckman Instruments, Inc. | BECKMAN ELECTROPHORESIS OVEN/INCUBATOR | 1979-07-24 | 42 |
Recalls for JRJ devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-06-07.
| Year | Recalls |
|---|---|
| 2017 | 3 |
Frequently asked questions
What is FDA product code JRJ?
JRJ is the FDA product code for unit, drying. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JRJ?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JRJ?
Across 1 cleared submissions the average was 42 days from receipt to decision (median 42).
Which companies have the most JRJ clearances?
Beckman Instruments, Inc. (1).
Have JRJ devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2017-06-07.
Next steps
- Run an FDA pathway report with predicate devices for product code JRJ
- Run a recall and safety report across every JRJ manufacturer
- Watch product code JRJ 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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