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 Sigma Diagnostics with 164 510(k) clearances. The most recent is a 510(k) clearance dated Aug 30, 2002: AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY C….
| Aug 30, 2002 | AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK021162 · JPA | 510(k) clearances |
| Feb 6, 2002 | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK020109 · GGC | 510(k) clearances |
| Dec 26, 2001 | SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013549 · DAP | 510(k) clearances |
| Nov 15, 2001 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K013545 · DAP | 510(k) clearances |
| Nov 15, 2001 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013544 · DAP | 510(k) clearances |
| Oct 26, 2001 | INFINITY HBA KIT, MODELS 537-A, 537-BK012410 · LCP | 510(k) clearances |
| Mar 30, 2001 | SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936K010652 · JIX | 510(k) clearances |
| Mar 22, 2001 | THROMBOMAX-HS WITH CALCIUM, MODEL T6540K010158 · GGO | 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
