Product code NBK
- Device name
- System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.1860
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K994356 | IMMUNOCYT | Diagnocure, Inc. | 2000-02-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08806162165883 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162166026 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162166019 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162166002 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162165999 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162165982 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162165975 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162165968 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162165951 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162165944 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162165937 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162165920 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162165913 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162165906 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162165890 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162165876 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162165869 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162165852 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-12-07 |
| 08806162111477 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-02-07 |
| 08806162117738 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-02-07 |
| 08806162111583 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-02-07 |
| 08806162111576 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-02-07 |
| 08806162111569 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-02-07 |
| 08806162111552 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-02-07 |
| 08806162111545 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-02-07 |
| 08806162111521 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-02-07 |
| 08806162111514 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-02-07 |
| 08806162111507 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-02-07 |
| 08806162111491 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-02-07 |
| 08806162111484 | AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2017-02-07 |