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 Sanofi. FDA records under its name, each linked to the record. See the Sanofi group view.
As of Nov 13, 2026, FDA's public records list Genzyme Diagnostics with 5 510(k) clearances. The most recent is a 510(k) clearance dated Apr 12, 2005: OSOM HCG COMBO TEST.
| Date | Record | Source |
|---|---|---|
| Apr 12, 2005 | OSOM HCG COMBO TESTK043385 · JHI | 510(k) clearances |
| Jan 11, 1999 | GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYK983399 · MHI | 510(k) clearances |
| Feb 25, 1997 | GENZYME DIAGNOSTICS CONTRAST MONOK963425 · KTN | 510(k) clearances |
| Nov 25, 1996 | CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TESTK964155 · JHI | 510(k) clearances |
| Nov 25, 1996 | CONTRAST STRIP HCGK964156 · JHI | 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
