FDA product code JGK: Ferric Chloride, Phenylketones (Urinary, Non-Quant.)
JGK is the FDA product code for ferric chloride, phenylketones (urinary, non-quant.). It is a Class I device, regulated under 21 CFR 862.1560 and reviewed by the Clinical Chemistry panel. Devices under JGK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Ferric Chloride, Phenylketones (Urinary, Non-Quant.) |
| Device class | Class I |
| Regulation | 21 CFR 862.1560 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JGK devices
openFDA lists no recalls for product code JGK.
Frequently asked questions
What is FDA product code JGK?
JGK is the FDA product code for ferric chloride, phenylketones (urinary, non-quant.). It is a Class I device, regulated under 21 CFR 862.1560 and reviewed by the Clinical Chemistry panel.
What device class is JGK?
Class I, regulation 21 CFR 862.1560. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JGK
- Run a recall and safety report across every JGK manufacturer
- Watch product code JGK 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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