FDA product code JMB: Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase
JMB is the FDA product code for visual, semi-quant. (colorimetric), 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 JMB. The average 510(k) review took 28 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Visual, Semi-Quant. (Colorimetric), 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 JMB clearance
Top JMB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hybritech, Inc. | 1 | 1985-03-21 |
Most recent JMB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K850680 | Hybritech, Inc. | ENCORE FERRITIN REAGENT | 1985-03-21 | 28 |
Recalls for JMB devices
openFDA lists no recalls for product code JMB.
Frequently asked questions
What is FDA product code JMB?
JMB is the FDA product code for visual, semi-quant. (colorimetric), 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 JMB?
Class II, regulation 21 CFR 864.7360. Typical premarket route: 510(k).
How long does a 510(k) take for product code JMB?
Across 1 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most JMB clearances?
Hybritech, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JMB
- Run a recall and safety report across every JMB manufacturer
- Watch product code JMB 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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