FDA product code JIB: U.V. Method, Galactose
JIB is the FDA product code for u.v. method, galactose. It is a Class I device, regulated under 21 CFR 862.1310 and reviewed by the Clinical Chemistry panel. Devices under JIB reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | U.V. Method, Galactose |
| Device class | Class I |
| Regulation | 21 CFR 862.1310 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for JIB devices
openFDA lists no recalls for product code JIB.
Frequently asked questions
What is FDA product code JIB?
JIB is the FDA product code for u.v. method, galactose. It is a Class I device, regulated under 21 CFR 862.1310 and reviewed by the Clinical Chemistry panel.
What device class is JIB?
Class I, regulation 21 CFR 862.1310. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code JIB
- Run a recall and safety report across every JIB manufacturer
- Watch product code JIB 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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