FDA product code JHH: Electrophoretic Method, Lecithin/Sphingomyelin Ratio
JHH is the FDA product code for electrophoretic method, lecithin/sphingomyelin ratio. It is a Class II device, regulated under 21 CFR 862.1455 and reviewed by the Clinical Chemistry panel. Devices under JHH reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Electrophoretic Method, Lecithin/Sphingomyelin Ratio |
| Device class | Class II |
| Regulation | 21 CFR 862.1455 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for JHH devices
openFDA lists no recalls for product code JHH.
Frequently asked questions
What is FDA product code JHH?
JHH is the FDA product code for electrophoretic method, lecithin/sphingomyelin ratio. It is a Class II device, regulated under 21 CFR 862.1455 and reviewed by the Clinical Chemistry panel.
What device class is JHH?
Class II, regulation 21 CFR 862.1455. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code JHH
- Run a recall and safety report across every JHH manufacturer
- Watch product code JHH 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.
All Clinical Chemistry product codes · FDA product code lookup