Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in AustraliaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Vital Diagnostics (Manufacturing) Pty Ltd and its 1 subsidiaries with 6 510(k) clearances and 2 device recalls. The most recent is a device recall dated Aug 29, 2013: Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the ….
| Aug 29, 2013 | Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and seClass II · High positive calcium bias on plasma sample versus results on serum | Device recalls |
| Aug 29, 2013 | Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and seClass II · High positive calcium bias on plasma sample versus results on serum | Device recalls |
| Aug 22, 2012 | EON CALCIUM REGENTK120626 · CJY | 510(k) clearances |
| Jul 27, 2012 | EON CHOLESTEROL REAGENTK120202 · CHH | 510(k) clearances |
| Nov 9, 2011 | CPK REAGENTK112416 · CGS | 510(k) clearances |
| Jun 28, 2011 | VITAL SERUM CONTROLSK111063 · JJY | 510(k) clearances |
| Jun 9, 2011 | ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)K110394 · JIX | 510(k) clearances |
| Dec 15, 2010 | EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475K100060 · KHS | 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
