FDA product code JBK: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic
JBK is the FDA product code for glucose-6-phosphate dehydrogenase (erythrocytic), u.v. kinetic. It is a Class II device, regulated under 21 CFR 864.7360 and reviewed by the Hematology panel. Devices under JBK reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic |
| Device class | Class II |
| Regulation | 21 CFR 864.7360 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for JBK devices
openFDA lists no recalls for product code JBK.
Frequently asked questions
What is FDA product code JBK?
JBK is the FDA product code for glucose-6-phosphate dehydrogenase (erythrocytic), u.v. kinetic. It is a Class II device, regulated under 21 CFR 864.7360 and reviewed by the Hematology panel.
What device class is JBK?
Class II, regulation 21 CFR 864.7360. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code JBK
- Run a recall and safety report across every JBK manufacturer
- Watch product code JBK 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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