MMW
9 FDA 510(k) clearances · Product code
120 daysmedian time to decision
912 days90th percentile
9clearances measured
FDA profile
- Official device name
- System, Test, Tumor Marker, Monitoring, Bladder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C (K203245) | Nucleix , Ltd. | 2023-05-04 |
| MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST (K033982) | Vysis | 2004-01-22 |
| NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT (K021231) | Matritech, Inc. | 2002-07-30 |
| UROVYSION BLADDER CANCER RECURRENCE KIT (K013785) | Vysis | 2002-02-08 |
| VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT (K011031) | Vysis | 2001-08-03 |
| BTA STAT TEST PRESCRIPTION HOME USE (K974845) | Bard Diagnostic Sciences,Inc. | 1998-12-08 |
| BARD BTA TRAK TEST (K971402) | Bard Diagnostic Sciences,Inc. | 1998-04-15 |
| AURA TEK FDP (K970353) | Perimmune, Inc. | 1997-04-30 |
| BARD AND BTA TEST (K964151) | Bard Diagnostic Sciences,Inc. | 1997-04-16 |
Track MMW automatically
Every clearance here is in the API, with alerts when new ones post.