Company ยท US
Vysis
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2004. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MMW | System, Test, Tumor Marker, Monitoring, Bladder | 4 |
| OYU | Dna-Probe Kit, Human Chromosome | 3 |
| NTH | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | 1 |
| OVQ | Chronic Lymphocytic Leukemia Fish Probe Kit | 1 |
| OXP | Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 13, 2004 | DEN040010 | VYSIS AUTOVYSION SYSTEM Vysis | NTH |
| Jan 22, 2004 | K033982 | MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST Vysis | MMW |
| Feb 8, 2002 | K013785 | UROVYSION BLADDER CANCER RECURRENCE KIT Vysis | MMW |
| Aug 3, 2001 | K011031 | VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT Vysis | MMW |
| Apr 13, 2001 | K010288 | ANEUVYSION MULITICOLOR DNA PROBE KIT Vysis | OYU |
| Oct 20, 1997 | K972200 | ANEUVYSION Vysis | OYU |
| Jan 21, 1997 | K954214 | CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT Vysis | OXP |
| Jan 13, 1997 | K962873 | CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE Vysis | OVQ |
| Nov 29, 1996 | K953591 | CEP 8 SPECTRUMORANGE DNA PROBE KIT Vysis | OYU |