Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Merck KGaA. FDA records under its name, each linked to the record. See the Merck KGaA group view.
As of Nov 15, 2026, FDA's public records list Serono-Baker Diagnostics with 23 510(k) clearances. The most recent is a 510(k) clearance dated Nov 30, 1992: TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY.
| Nov 30, 1992 | TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAYK924257 · CDZ | 510(k) clearances |
| Mar 2, 1992 | SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)K914886 · CGR | 510(k) clearances |
| Mar 2, 1992 | SRI TESTOSTERONE ENZYME IMMUNOASSAYK915164 · CDZ | 510(k) clearances |
| Jan 17, 1992 | SRI DIGOXIN ENZYME IMMUNOASSAYK915602 · KXT | 510(k) clearances |
| Nov 19, 1991 | SR1 FREE T4 ENZYME IMMUNOASSAYK912937 · CEC | 510(k) clearances |
| Oct 23, 1991 | SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)K914462 · JLS | 510(k) clearances |
| Sep 18, 1991 | SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)K911912 · KHQ | 510(k) clearances |
| Aug 16, 1991 | SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)K911217 · KLI | 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
