FDA product code JBE: Cell Enzymes (Erythrocytic And Leukocytic)
JBE is the FDA product code for cell enzymes (erythrocytic and leukocytic). It is a Class II device, regulated under 21 CFR 864.7100 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under JBE. The average 510(k) review took 86 days (median 86).
Classification
| Field | Value |
|---|---|
| Device name | Cell Enzymes (Erythrocytic And Leukocytic) |
| Device class | Class II |
| Regulation | 21 CFR 864.7100 |
| 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 JBE clearance
Top JBE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1982-12-03 |
Most recent JBE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822733 | Sigma Chemical Co. | SIGMA REAGENT SYSTEM NO. 885 | 1982-12-03 | 86 |
Recalls for JBE devices
openFDA lists no recalls for product code JBE.
Frequently asked questions
What is FDA product code JBE?
JBE is the FDA product code for cell enzymes (erythrocytic and leukocytic). It is a Class II device, regulated under 21 CFR 864.7100 and reviewed by the Hematology panel.
What device class is JBE?
Class II, regulation 21 CFR 864.7100. Typical premarket route: 510(k).
How long does a 510(k) take for product code JBE?
Across 1 cleared submissions the average was 86 days from receipt to decision (median 86).
Which companies have the most JBE clearances?
Sigma Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JBE
- Run a recall and safety report across every JBE manufacturer
- Watch product code JBE 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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