Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Sweden Diagnostics with 9 510(k) clearances. The most recent is a 510(k) clearance dated Aug 3, 2006: ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01.
| Aug 3, 2006 | ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01K061165 · NHX | 510(k) clearances |
| Jun 28, 2005 | VARELISA RECOMBI CTD SCREEN, MODEL 13096K050967 · LJM | 510(k) clearances |
| Apr 26, 2005 | VARELISA RECOMBI ANA PROFILE, MODEL 18496K050625 · LJM | 510(k) clearances |
| Dec 8, 2004 | VARELISA SM ANTIBODIES, MODEL 18296K042629 · LKP | 510(k) clearances |
| Aug 2, 2004 | CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996K041173 · MVM | 510(k) clearances |
| Aug 2, 2004 | VARELISA GLIADIN IGG ANTIBODIESK041357 · MST | 510(k) clearances |
| Jul 19, 2004 | CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196K041174 · MVM | 510(k) clearances |
| Jul 16, 2004 | VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896K041354 · MST | 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
