Product code NBK— Hematology
IMMUNOCYT
- Classification name
- System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer
- Device class
- Class 2
- Regulation
- 21 CFR 864.1860
- Advisory panel
- Hematology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code NBK
FDA has cleared device under product code NBK, all in 2000, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code NBK
Recent clearances under product code NBK
Data sourced from openFDA. This site is unofficial and independent of the FDA.