Vysis
Downers Grove, IL, US
Vysis appears in FDA device records in Downers Grove, IL. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Vysis between 1996 and 2004. The busiest year on record is 1997, with 3. The most recent is 2004, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 3 |
| 2001 | 2 |
| 2002 | 1 |
| 2004 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| DEN040010 | VYSIS AUTOVYSION SYSTEM | NTH | Unknown | |
| K033982 | MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST | MMW | Substantially Equivalent | |
| K013785 | UROVYSION BLADDER CANCER RECURRENCE KIT | MMW | Substantially Equivalent | |
| K011031 | VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT | MMW | Substantially Equivalent | |
| K010288 | ANEUVYSION MULITICOLOR DNA PROBE KIT | OYU | Substantially Equivalent | |
| K972200 | ANEUVYSION | OYU | Substantially Equivalent | |
| K954214 | CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT | OXP | Substantially Equivalent | |
| K962873 | CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE | OVQ | Substantially Equivalent | |
| K953591 | CEP 8 SPECTRUMORANGE DNA PROBE KIT | OYU | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- OVQChronic Lymphocytic Leukemia Fish Probe Kit
- OYUDna-Probe Kit, Human Chromosome
- OXPDna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
- NTHSystem, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
- MMWSystem, Test, Tumor Marker, Monitoring, Bladder
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain