Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C
FDA 510(k) clearance K203245 · decided 2023-05-04
Clearance details
- K-number
- K203245
- Device name
- Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C
- Applicant
- Nucleix , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-11-03
- Decision date
- 2023-05-04
- Days to decision
- 912 days
- Clearance type
- Traditional
- Product code
- MMW
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Rehovot, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.