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 System with 1 510(k) clearance. The most recent is a 510(k) clearance dated Sep 13, 1991: SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER.
| Date | Record | Source |
|---|---|---|
| Sep 13, 1991 | SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTERK911626 ยท GKZ | 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
