FDA product code JKG: L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase
JKG is the FDA product code for l-isocitrate and nadp (u.v.), isocitric dehydrogenase. It is a Class I device, regulated under 21 CFR 862.1420 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JKG. The average 510(k) review took 77 days (median 77).
Classification
| Field | Value |
|---|---|
| Device name | L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase |
| Device class | Class I |
| Regulation | 21 CFR 862.1420 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JKG clearance
Top JKG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1977-06-03 |
Most recent JKG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K770519 | Sigma Chemical Co. | REAGENT SYSTEM 153-UV | 1977-06-03 | 77 |
Recalls for JKG devices
openFDA lists no recalls for product code JKG.
Frequently asked questions
What is FDA product code JKG?
JKG is the FDA product code for l-isocitrate and nadp (u.v.), isocitric dehydrogenase. It is a Class I device, regulated under 21 CFR 862.1420 and reviewed by the Clinical Chemistry panel.
What device class is JKG?
Class I, regulation 21 CFR 862.1420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JKG?
Across 1 cleared submissions the average was 77 days from receipt to decision (median 77).
Which companies have the most JKG clearances?
Sigma Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JKG
- Run a recall and safety report across every JKG manufacturer
- Watch product code JKG 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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