FDA product code JIC: Colorimetric Method, Galactose
JIC is the FDA product code for colorimetric method, galactose. It is a Class I device, regulated under 21 CFR 862.1310 and reviewed by the Clinical Chemistry panel. Devices under JIC reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Colorimetric 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 JIC devices
openFDA lists no recalls for product code JIC.
Frequently asked questions
What is FDA product code JIC?
JIC is the FDA product code for colorimetric 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 JIC?
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 JIC
- Run a recall and safety report across every JIC manufacturer
- Watch product code JIC 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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