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 Siemens HealthineersLabelled 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 15, 2026, FDA's public records list Dade Chemistry Systems with 13 510(k) clearances. The most recent is a 510(k) clearance dated Oct 20, 1997: TROPONIN (TROP) METHOD.
| Oct 20, 1997 | TROPONIN (TROP) METHODK973650 · MMI | 510(k) clearances |
| Sep 29, 1997 | PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATORK973100 · JIT | 510(k) clearances |
| Sep 29, 1997 | PROSTATE SPECIFIC ANTIGEN CONTROLK973099 · JJX | 510(k) clearances |
| Sep 18, 1997 | PROSTATE SPECIFIC ANTIGEN METHODK973101 · LTJ | 510(k) clearances |
| Apr 28, 1997 | FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEMK971141 · CEC | 510(k) clearances |
| Mar 10, 1997 | HUMAN CHORIONIC GONADOTROPIN METHODK970387 · DHA | 510(k) clearances |
| Mar 3, 1997 | THYROID STIMULATING HORMONE METHODK970393 · JLW | 510(k) clearances |
| Mar 3, 1997 | MMB CALIBRATORK970336 · JIT | 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
