Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Roche. FDA records under its name, each linked to the record. See the Roche group view.
As of Nov 14, 2026, FDA's public records list Roche Image Analysis Systems with 1 510(k) clearance. The most recent is a 510(k) clearance dated Dec 15, 1995: IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM.
| Date | Record | Source |
|---|---|---|
| Dec 15, 1995 | IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUMK952490 ยท LJM | 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
