FDA product code JRB: Micro Mixer
JRB is the FDA product code for micro mixer. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. Devices under JRB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for JRB devices.
Classification
| Field | Value |
|---|---|
| Device name | Micro Mixer |
| 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 |
Recalls for JRB devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-10-10.
Frequently asked questions
What is FDA product code JRB?
JRB is the FDA product code for micro mixer. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JRB?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
Have JRB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-10-10.
Next steps
- Run an FDA pathway report with predicate devices for product code JRB
- Run a recall and safety report across every JRB manufacturer
- Watch product code JRB 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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