Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled 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 14, 2026, FDA's public records list Elitechgroup with 18 510(k) clearances. The most recent is a 510(k) clearance dated Oct 29, 2018: HSV 1 & 2 ELITe MGB Kit; ELITe InGenius.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 29, 2018 | HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusK180559 · PGI | 510(k) clearances |
| Jul 27, 2018 | Macroduct Advanced Model 3710K180627 · KTB | 510(k) clearances |
| Jul 11, 2017 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1K171401 · CIG | 510(k) clearances |
| Sep 7, 2016 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIK153644 · CFR | 510(k) clearances |
| Jul 22, 2015 | ELITech Clinical Systems CALCIUM ARSENAZOK151113 · CJY | 510(k) clearances |
| Jul 8, 2015 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL IIK151552 · JIX | 510(k) clearances |
| Jul 18, 2014 | ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KITK141265 · JHW | 510(k) clearances |
| Jan 3, 2014 | ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVELK132399 · JFY | 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
