FDA product code JKF: Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
JKF is the FDA product code for dinitrophenyl hydrazone measurement (colorimetric), hydroxybutyric dehydroge. It is a Class I device, regulated under 21 CFR 862.1380 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under JKF, from 2 different applicants. The average 510(k) review took 50 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge |
| Device class | Class I |
| Regulation | 21 CFR 862.1380 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JKF clearance
Top JKF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sterling Diagnostics, Inc. | 1 | 1986-06-16 |
| Sterling Biochemical, Inc. | 1 | 1984-02-04 |
Most recent JKF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K861855 | Sterling Diagnostics, Inc. | HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET | 1986-06-16 | 33 |
| K834084 | Sterling Biochemical, Inc. | HYDROXYBUTYRATE DEHYDROGENASE REAGENT | 1984-02-04 | 68 |
Recalls for JKF devices
openFDA lists no recalls for product code JKF.
Frequently asked questions
What is FDA product code JKF?
JKF is the FDA product code for dinitrophenyl hydrazone measurement (colorimetric), hydroxybutyric dehydroge. It is a Class I device, regulated under 21 CFR 862.1380 and reviewed by the Clinical Chemistry panel.
What device class is JKF?
Class I, regulation 21 CFR 862.1380. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JKF?
Across 2 cleared submissions the average was 50 days from receipt to decision (median 50).
Which companies have the most JKF clearances?
Sterling Diagnostics, Inc. (1); Sterling Biochemical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JKF
- Run a recall and safety report across every JKF manufacturer
- Watch product code JKF 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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