FDA product code JPB: Hemoglobin M
JPB is the FDA product code for hemoglobin m. It is a Class II device, regulated under 21 CFR 864.7415 and reviewed by the Hematology panel. Devices under JPB reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for JPB devices.
Classification
| Field | Value |
|---|---|
| Device name | Hemoglobin M |
| Device class | Class II |
| Regulation | 21 CFR 864.7415 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for JPB devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-02-24.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code JPB?
JPB is the FDA product code for hemoglobin m. It is a Class II device, regulated under 21 CFR 864.7415 and reviewed by the Hematology panel.
What device class is JPB?
Class II, regulation 21 CFR 864.7415. Typical premarket route: 510(k).
Have JPB devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2017-02-24.
Next steps
- Run an FDA pathway report with predicate devices for product code JPB
- Run a recall and safety report across every JPB manufacturer
- Watch product code JPB 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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