FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
VYSIS AUTOVYSION SYSTEM
K Number: DEN040010
·
Decision Dec 13, 2004
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
7
Applicant Total
9
Review Days
61
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Basic Information
- Device Name
- VYSIS AUTOVYSION SYSTEM
- K Number
- DEN040010
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 866.4700
- Medical Specialty
- Immunology
- Decision
- Unknown
- Applicant
- Vysis
- Date Received
- October 13, 2004
- Decision Date
- December 13, 2004
- Product Code
- NTH
- Advisory Committee
- Immunology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| NTH | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | FDA class 2 | Immunology |
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Other Clearances by Vysis
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |