FDA product code KQE: Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase
KQE is the FDA product code for assay, erythrocytic glucose-6-phosphate dehydrogenase. It is a Class II device, regulated under 21 CFR 864.7360 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under KQE. The average 510(k) review took 39 days (median 39).
Classification
| Field | Value |
|---|---|
| Device name | Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase |
| Device class | Class II |
| Regulation | 21 CFR 864.7360 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KQE clearance
Top KQE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alladin Diagnostic, Inc. | 1 | 1983-02-07 |
Most recent KQE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823900 | Alladin Diagnostic, Inc. | GLUCOSE-6-PHOSPHATE DEHYDROGENASE | 1983-02-07 | 39 |
Recalls for KQE devices
openFDA lists no recalls for product code KQE.
Frequently asked questions
What is FDA product code KQE?
KQE is the FDA product code for assay, erythrocytic glucose-6-phosphate dehydrogenase. It is a Class II device, regulated under 21 CFR 864.7360 and reviewed by the Hematology panel.
What device class is KQE?
Class II, regulation 21 CFR 864.7360. Typical premarket route: 510(k).
How long does a 510(k) take for product code KQE?
Across 1 cleared submissions the average was 39 days from receipt to decision (median 39).
Which companies have the most KQE clearances?
Alladin Diagnostic, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KQE
- Run a recall and safety report across every KQE manufacturer
- Watch product code KQE 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.
All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times