FDA product code KZS: Chromatography (Thin Layer), Clinical Use
KZS is the FDA product code for chromatography (thin layer), clinical use. It is a Class I device, regulated under 21 CFR 862.2270 and reviewed by the Clinical Toxicology panel. Devices under KZS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Chromatography (Thin Layer), Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2270 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for KZS devices
openFDA lists no recalls for product code KZS.
Frequently asked questions
What is FDA product code KZS?
KZS is the FDA product code for chromatography (thin layer), clinical use. It is a Class I device, regulated under 21 CFR 862.2270 and reviewed by the Clinical Toxicology panel.
What device class is KZS?
Class I, regulation 21 CFR 862.2270. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KZS
- Run a recall and safety report across every KZS manufacturer
- Watch product code KZS 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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