Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of AbbottLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Vysis with 8 510(k) clearances. The most recent is a 510(k) clearance dated Dec 13, 2004: VYSIS AUTOVYSION SYSTEM.
| Date | Record | Source |
|---|---|---|
| Dec 13, 2004 | VYSIS AUTOVYSION SYSTEMDEN040010 · NTH | 510(k) clearances |
| Jan 22, 2004 | MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TESTK033982 · MMW | 510(k) clearances |
| Feb 8, 2002 | UROVYSION BLADDER CANCER RECURRENCE KITK013785 · MMW | 510(k) clearances |
| Aug 3, 2001 | VYSIS UROVYSION BLADDER CANCER RECURRENCE KITK011031 · MMW | 510(k) clearances |
| Apr 13, 2001 | ANEUVYSION MULITICOLOR DNA PROBE KITK010288 · OYU | 510(k) clearances |
| Oct 20, 1997 | ANEUVYSIONK972200 · OYU | 510(k) clearances |
| Jan 21, 1997 | CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KITK954214 · OXP | 510(k) clearances |
| Jan 13, 1997 | CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBEK962873 · OVQ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
