Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwitzerlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Roche. FDA records under 3 spellings of its name, each linked to the record. See the Roche group view.
As of Nov 14, 2026, FDA's public records list Hoffmann-La Roche with 49 510(k) clearances and 12 drug applications. The most recent is a 510(k) clearance dated Jun 25, 1985: BHCG-ROCHE EIA.
| Jun 25, 1985 | BHCG-ROCHE EIAK850727 · JHI | 510(k) clearances |
| Jul 19, 1983 | RENAKK831694 · CIB | 510(k) clearances |
| Mar 24, 1983 | ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONEK830461 · KXS | 510(k) clearances |
| Mar 24, 1983 | ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINEK830481 · LCL | 510(k) clearances |
| Mar 24, 1983 | ABUSCREEN RADIOIMMUNOASSAY-COCAINE METAK830480 · KLN | 510(k) clearances |
| Mar 24, 1983 | ABUSCREEN RADIOUMMUNOASSAY--URINEK830462 · DOE | 510(k) clearances |
| Mar 24, 1983 | ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINEK830482 · DJP | 510(k) clearances |
| Mar 24, 1983 | ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINEK830460 · DOE | 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
