FDA product code GJC: Assay, Sulfhemoglobin
GJC is the FDA product code for assay, sulfhemoglobin. It is a Class II device, regulated under 21 CFR 864.7490 and reviewed by the Hematology panel. Devices under GJC reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Assay, Sulfhemoglobin |
| Device class | Class II |
| Regulation | 21 CFR 864.7490 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for GJC devices
openFDA lists no recalls for product code GJC.
Frequently asked questions
What is FDA product code GJC?
GJC is the FDA product code for assay, sulfhemoglobin. It is a Class II device, regulated under 21 CFR 864.7490 and reviewed by the Hematology panel.
What device class is GJC?
Class II, regulation 21 CFR 864.7490. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code GJC
- Run a recall and safety report across every GJC manufacturer
- Watch product code GJC 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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