FDA product code JSB: Culture Media, Vitamin Assay
JSB is the FDA product code for culture media, vitamin assay. It is a Class I device, regulated under 21 CFR 866.2350 and reviewed by the Microbiology panel. Devices under JSB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Vitamin Assay |
| Device class | Class I |
| Regulation | 21 CFR 866.2350 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for JSB devices
openFDA lists no recalls for product code JSB.
Frequently asked questions
What is FDA product code JSB?
JSB is the FDA product code for culture media, vitamin assay. It is a Class I device, regulated under 21 CFR 866.2350 and reviewed by the Microbiology panel.
What device class is JSB?
Class I, regulation 21 CFR 866.2350. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JSB
- Run a recall and safety report across every JSB manufacturer
- Watch product code JSB 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 Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times