FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
K Number: K011031
·
Decision Aug 3, 2001
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
8
Applicant Total
9
Review Days
120
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Basic Information
- Device Name
- VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
- K Number
- K011031
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vysis
- Date Received
- April 5, 2001
- Decision Date
- August 3, 2001
- 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
Other 510(k) clearances with the same product code (MMW), ordered by most recent decision date.
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 |
| K013785 | UROVYSION BLADDER CANCER RECURRENCE KIT | Feb 8, 2002 | 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 |