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 Merck KGaALabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. 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 EM Diagnostic Systems with 288 510(k) clearances. The most recent is a 510(k) clearance dated Jan 27, 1994: ASPARTATE AMINOTRANSFERASE (AST) TEST.
| Jan 27, 1994 | ASPARTATE AMINOTRANSFERASE (AST) TESTK935181 · CIT | 510(k) clearances |
| Jan 13, 1994 | ALANINE AMINOTRANSFERASE (ALT) TESTK935180 · CKA | 510(k) clearances |
| Dec 17, 1993 | EMDS ALBUMIN (ALB) TESTK935179 · CIX | 510(k) clearances |
| Dec 17, 1993 | EMDS PHOSPHOROUS (PHOS) TESTK935178 · CEO | 510(k) clearances |
| Dec 16, 1993 | TOTAL PROTEIN TEST (TPRO)K935174 · CEK | 510(k) clearances |
| Dec 16, 1993 | CHOLESTEROL (CHOL) TEST ITEM NO. 65410K935136 · CHH | 510(k) clearances |
| Dec 16, 1993 | LACTATE DEHYDROGENASE (LD)K935175 · CFJ | 510(k) clearances |
| Dec 16, 1993 | IRON TESTK935176 · JIY | 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
