FDA product code KLJ: Nad Reduction (U.V.), Phosphohexose Isomerase
KLJ is the FDA product code for nad reduction (u.v.), phosphohexose isomerase. It is a Class I device, regulated under 21 CFR 862.1570 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under KLJ. The average 510(k) review took 81 days (median 81).
Classification
| Field | Value |
|---|---|
| Device name | Nad Reduction (U.V.), Phosphohexose Isomerase |
| Device class | Class I |
| Regulation | 21 CFR 862.1570 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KLJ clearance
Top KLJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1977-06-17 |
Most recent KLJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K770577 | Sigma Chemical Co. | DETER. OF PHOSPHOHEXOSE ISOMERASE | 1977-06-17 | 81 |
Recalls for KLJ devices
openFDA lists no recalls for product code KLJ.
Frequently asked questions
What is FDA product code KLJ?
KLJ is the FDA product code for nad reduction (u.v.), phosphohexose isomerase. It is a Class I device, regulated under 21 CFR 862.1570 and reviewed by the Clinical Chemistry panel.
What device class is KLJ?
Class I, regulation 21 CFR 862.1570. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KLJ?
Across 1 cleared submissions the average was 81 days from receipt to decision (median 81).
Which companies have the most KLJ clearances?
Sigma Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KLJ
- Run a recall and safety report across every KLJ manufacturer
- Watch product code KLJ 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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