FDA product code JCI: Acid Phosphatase, Cytochemical
JCI is the FDA product code for acid phosphatase, cytochemical. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. Devices under JCI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Acid Phosphatase, Cytochemical |
| 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 JCI devices
openFDA lists no recalls for product code JCI.
Frequently asked questions
What is FDA product code JCI?
JCI is the FDA product code for acid phosphatase, cytochemical. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is JCI?
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 JCI
- Run a recall and safety report across every JCI manufacturer
- Watch product code JCI 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.