FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UROVYSION BLADDER CANCER RECURRENCE KIT
K Number: K013785
·
Decision Feb 8, 2002
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
8
Applicant Total
9
Review Days
86
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Basic Information
- Device Name
- UROVYSION BLADDER CANCER RECURRENCE KIT
- K Number
- K013785
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vysis
- Date Received
- November 14, 2001
- Decision Date
- February 8, 2002
- Product Code
- MMW
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MMW | System, Test, Tumor Marker, Monitoring, Bladder | FDA class 2 | Immunology |
Similar 510(k) Clearances
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Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C
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Other Clearances by Vysis
| K Number | Device Name | ||
|---|---|---|---|
| DEN040010 | VYSIS AUTOVYSION SYSTEM | Dec 13, 2004 | Unknown |
| K033982 | MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST | Jan 22, 2004 | Substantially Equivalent |
| K011031 | VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT | Aug 3, 2001 | Substantially Equivalent |
| K010288 | ANEUVYSION MULITICOLOR DNA PROBE KIT | Apr 13, 2001 | Substantially Equivalent |
| K972200 | ANEUVYSION | Oct 20, 1997 | Substantially Equivalent |
| K954214 | CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT | Jan 21, 1997 | Substantially Equivalent |
| K962873 | CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE | Jan 13, 1997 | Substantially Equivalent |
| K953591 | CEP 8 SPECTRUMORANGE DNA PROBE KIT | Nov 29, 1996 | Substantially Equivalent |