FDA product code JBS: Timer, General Laboratory
JBS is the FDA product code for timer, general laboratory. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. Devices under JBS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for JBS devices.
Classification
| Field | Value |
|---|---|
| Device name | Timer, General Laboratory |
| 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 JBS devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-06-23.
Frequently asked questions
What is FDA product code JBS?
JBS is the FDA product code for timer, general laboratory. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JBS?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
Have JBS devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2015-06-23.
Next steps
- Run an FDA pathway report with predicate devices for product code JBS
- Run a recall and safety report across every JBS manufacturer
- Watch product code JBS 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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