FDA product code JBW: Red-Cell Indices, Measured
JBW is the FDA product code for red-cell indices, measured. It is a Class II device, regulated under 21 CFR 864.5300 and reviewed by the Hematology panel. Devices under JBW reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Red-Cell Indices, Measured |
| Device class | Class II |
| Regulation | 21 CFR 864.5300 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for JBW devices
openFDA lists no recalls for product code JBW.
Frequently asked questions
What is FDA product code JBW?
JBW is the FDA product code for red-cell indices, measured. It is a Class II device, regulated under 21 CFR 864.5300 and reviewed by the Hematology panel.
What device class is JBW?
Class II, regulation 21 CFR 864.5300. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code JBW
- Run a recall and safety report across every JBW manufacturer
- Watch product code JBW 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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