Product code MMW
- Device name
- System, Test, Tumor Marker, Monitoring, Bladder
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.6010
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203245 | Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C | Nucleix , Ltd. | 2023-05-04 |
| K033982 | MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST | Vysis | 2004-01-22 |
| K021231 | NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT | Matritech, Inc. | 2002-07-30 |
| K013785 | UROVYSION BLADDER CANCER RECURRENCE KIT | Vysis | 2002-02-08 |
| K011031 | VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT | Vysis | 2001-08-03 |
| K974845 | BTA STAT TEST PRESCRIPTION HOME USE | Bard Diagnostic Sciences,Inc. | 1998-12-08 |
| K971402 | BARD BTA TRAK TEST | Bard Diagnostic Sciences,Inc. | 1998-04-15 |
| K970353 | AURA TEK FDP | Perimmune, Inc. | 1997-04-30 |
| K964151 | BARD AND BTA TEST | Bard Diagnostic Sciences,Inc. | 1997-04-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07290019028000 | Bladder EpiCheck Extraction Kit | NUCLEIX LTD | 2023-10-13 |
| 07290019028208 | Bladder EpiCheck Test Kit | NUCLEIX LTD | 2023-10-13 |
| 00811877011538 | NMP22 BladderChek Test | Alere Scarborough, Inc. | 2022-08-08 |
| 00811877011552 | NMP22 BladderChek Control Kit | Alere Scarborough, Inc. | 2022-08-08 |
| 10743816001393 | Status BTA Card | PRINCETON BIOMEDITECH CORPORATION | 2016-11-30 |
| 10743816001409 | Status BTA Card | PRINCETON BIOMEDITECH CORPORATION | 2016-11-30 |
| 00855574005636 | BTA stat | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | 2016-09-23 |
| 00855574005285 | BTA TRAK | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | 2016-09-23 |
| 00855574005629 | BTA stat | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | 2016-09-23 |
| 00855574005353 | BTA stat | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | 2016-09-23 |
| 00855574005278 | BTA stat | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | 2016-09-23 |
| 00855574005261 | BTA stat | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | 2016-09-23 |
| 00855574005001 | BTA stat | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | 2016-09-23 |
| 00855574005292 | BTA TRAK | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | 2016-09-23 |
| 10811877010606 | Alere NMP22 BladderChek Control Kit | Alere Scarborough, Inc. | 2014-09-01 |
| 10811877010774 | Alere NMP22 BladderChek Test | Alere Scarborough, Inc. | 2014-09-01 |
| 10811877010569 | Alere NMP22 BladderChek Test | Alere Scarborough, Inc. | 2014-09-01 |