FDA product code JCH: Esterase
JCH is the FDA product code for esterase. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. Devices under JCH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Esterase |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for JCH devices
openFDA lists no recalls for product code JCH.
Frequently asked questions
What is FDA product code JCH?
JCH is the FDA product code for esterase. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is JCH?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JCH
- Run a recall and safety report across every JCH manufacturer
- Watch product code JCH 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.