FDA product code NBK: System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer
NBK is the FDA product code for system, test, (ihc), tumor marker, monitoring, bladder cancer. It is a Class II device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under NBK. The average 510(k) review took 62 days (median 62).
Classification
| Field | Value |
|---|---|
| Device name | System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer |
| Device class | Class II |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NBK clearance
Top NBK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnocure, Inc. | 1 | 2000-02-23 |
Most recent NBK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K994356 | Diagnocure, Inc. | IMMUNOCYT | 2000-02-23 | 62 |
Recalls for NBK devices
openFDA lists no recalls for product code NBK.
Frequently asked questions
What is FDA product code NBK?
NBK is the FDA product code for system, test, (ihc), tumor marker, monitoring, bladder cancer. It is a Class II device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is NBK?
Class II, regulation 21 CFR 864.1860. Typical premarket route: 510(k).
How long does a 510(k) take for product code NBK?
Across 1 cleared submissions the average was 62 days from receipt to decision (median 62).
Which companies have the most NBK clearances?
Diagnocure, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NBK
- Run a recall and safety report across every NBK manufacturer
- Watch product code NBK 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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