NBK — System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer Class II
FDA product code NBK covers "System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer", a Class II medical device regulated under 21 CFR 864.1860. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NBK
- Device Class
- Class II
- Regulation Number
- 864.1860
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K994356 | diagnocure | IMMUNOCYT | February 23, 2000 |