FDA product code KZX: Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin
KZX is the FDA product code for kit, disc, agar gel diffusion, determine serum levels of tobramycin. It is a Class II device, regulated under 21 CFR 862.3900 and reviewed by the Clinical Toxicology panel. Devices under KZX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin |
| Device class | Class II |
| Regulation | 21 CFR 862.3900 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for KZX devices
openFDA lists no recalls for product code KZX.
Frequently asked questions
What is FDA product code KZX?
KZX is the FDA product code for kit, disc, agar gel diffusion, determine serum levels of tobramycin. It is a Class II device, regulated under 21 CFR 862.3900 and reviewed by the Clinical Toxicology panel.
What device class is KZX?
Class II, regulation 21 CFR 862.3900. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code KZX
- Run a recall and safety report across every KZX manufacturer
- Watch product code KZX 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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