FDA product code JLM: Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase
JLM is the FDA product code for isoenzymes, electrophoretic, 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 JLM. The average 510(k) review took 42 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Isoenzymes, Electrophoretic, 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 JLM clearance
Top JLM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boots-Celltech Diagnostics, Inc. | 1 | 1987-10-20 |
Most recent JLM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873625 | Boots-Celltech Diagnostics, Inc. | CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) | 1987-10-20 | 42 |
Recalls for JLM devices
openFDA lists no recalls for product code JLM.
Frequently asked questions
What is FDA product code JLM?
JLM is the FDA product code for isoenzymes, electrophoretic, 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 JLM?
Class II, regulation 21 CFR 864.7360. Typical premarket route: 510(k).
How long does a 510(k) take for product code JLM?
Across 1 cleared submissions the average was 42 days from receipt to decision (median 42).
Which companies have the most JLM clearances?
Boots-Celltech Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JLM
- Run a recall and safety report across every JLM manufacturer
- Watch product code JLM 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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