FDA product code JBO: Test, Euglobulin Lysis
JBO is the FDA product code for test, euglobulin lysis. It is a Class II device, regulated under 21 CFR 864.7275 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under JBO. The average 510(k) review took 68 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Test, Euglobulin Lysis |
| Device class | Class II |
| Regulation | 21 CFR 864.7275 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JBO clearance
Top JBO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Corp. | 1 | 1983-06-08 |
Most recent JBO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831055 | Olympus Corp. | HEMOGLOBIN ELECTROPHORESIS METH ON THE- | 1983-06-08 | 68 |
Recalls for JBO devices
openFDA lists no recalls for product code JBO.
Frequently asked questions
What is FDA product code JBO?
JBO is the FDA product code for test, euglobulin lysis. It is a Class II device, regulated under 21 CFR 864.7275 and reviewed by the Hematology panel.
What device class is JBO?
Class II, regulation 21 CFR 864.7275. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JBO?
Across 1 cleared submissions the average was 68 days from receipt to decision (median 68).
Which companies have the most JBO clearances?
Olympus Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JBO
- Run a recall and safety report across every JBO manufacturer
- Watch product code JBO 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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