FDA product code JKH: Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen
JKH is the FDA product code for hydrazone deriv. of alpha-ketogluterate (colorimetry), isocitric dehydrogen. 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 JKH. The average 510(k) review took 59 days (median 59).
Classification
| Field | Value |
|---|---|
| Device name | Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen |
| 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 JKH clearance
Top JKH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1977-07-14 |
Most recent JKH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K770902 | Sigma Chemical Co. | COLORIMETRIC DETERM. SOCITRATE DEHYDRO. | 1977-07-14 | 59 |
Recalls for JKH devices
openFDA lists no recalls for product code JKH.
Frequently asked questions
What is FDA product code JKH?
JKH is the FDA product code for hydrazone deriv. of alpha-ketogluterate (colorimetry), isocitric dehydrogen. It is a Class I device, regulated under 21 CFR 862.1420 and reviewed by the Clinical Chemistry panel.
What device class is JKH?
Class I, regulation 21 CFR 862.1420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JKH?
Across 1 cleared submissions the average was 59 days from receipt to decision (median 59).
Which companies have the most JKH clearances?
Sigma Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JKH
- Run a recall and safety report across every JKH manufacturer
- Watch product code JKH 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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