FDA Product Code
FDA Product Code MMW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6010
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203245 | Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C | Nucleix , Ltd. | 2023-05-04 | Traditional | PDF ↗ |
| K033982 | MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST | Vysis | 2004-01-22 | Special | PDF ↗ |
| K021231 | NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT | Matritech, Inc. | 2002-07-30 | Traditional | PDF ↗ |
| K013785 | UROVYSION BLADDER CANCER RECURRENCE KIT | Vysis | 2002-02-08 | Abbreviated | PDF ↗ |
| K011031 | VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT | Vysis | 2001-08-03 | Traditional | PDF ↗ |
| K974845 | BTA STAT TEST PRESCRIPTION HOME USE | Bard Diagnostic Sciences,Inc. | 1998-12-08 | Traditional | PDF ↗ |
| K971402 | BARD BTA TRAK TEST | Bard Diagnostic Sciences,Inc. | 1998-04-15 | Traditional | PDF ↗ |
| K970353 | AURA TEK FDP | Perimmune, Inc. | 1997-04-30 | Traditional | PDF ↗ |
| K964151 | BARD AND BTA TEST | Bard Diagnostic Sciences,Inc. | 1997-04-16 | Traditional | PDF ↗ |
Product code MMW · Class II · Immunology. Data: openFDA.