FDA product code JLI: Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid
JLI is the FDA product code for tetrahydrofolate, enzymatic (u.v.), formiminoglutamic acid. It is a Class I device, regulated under 21 CFR 862.1305 and reviewed by the Clinical Chemistry panel. Devices under JLI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid |
| Device class | Class I |
| Regulation | 21 CFR 862.1305 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JLI devices
openFDA lists no recalls for product code JLI.
Frequently asked questions
What is FDA product code JLI?
JLI is the FDA product code for tetrahydrofolate, enzymatic (u.v.), formiminoglutamic acid. It is a Class I device, regulated under 21 CFR 862.1305 and reviewed by the Clinical Chemistry panel.
What device class is JLI?
Class I, regulation 21 CFR 862.1305. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JLI
- Run a recall and safety report across every JLI manufacturer
- Watch product code JLI 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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