Panels › Immunology › Product code MMW · Class 2
System, Test, Tumor Marker, Monitoring, Bladder
Regulation 866.6010
0510(k)s in 12 months (9 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MMW
| Company | 510(k)s | Recalls |
|---|---|---|
| Vysis | 3 | 1 |
| Bard Diagnostic Sciences,Inc. | 3 | 0 |
| Matritech, Inc. | 1 | 0 |
| Nucleix , Ltd. | 1 | 0 |
| Perimmune, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 4, 2023 | K203245 | Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, N Nucleix , Ltd., IL | MMW |
| Jan 22, 2004 | K033982 | MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST Vysis | MMW |
| Jul 30, 2002 | K021231 | NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT Matritech, Inc. | MMW |
| Feb 8, 2002 | K013785 | UROVYSION BLADDER CANCER RECURRENCE KIT Vysis | MMW |
| Aug 3, 2001 | K011031 | VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT Vysis | MMW |
| Dec 8, 1998 | K974845 | BTA STAT TEST PRESCRIPTION HOME USE Bard Diagnostic Sciences,Inc. | MMW |
| Apr 15, 1998 | K971402 | BARD BTA TRAK TEST Bard Diagnostic Sciences,Inc. | MMW |
| Apr 30, 1997 | K970353 | AURA TEK FDP Perimmune, Inc. | MMW |
| Apr 16, 1997 | K964151 | BARD AND BTA TEST Bard Diagnostic Sciences,Inc. | MMW |
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