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As of Nov 15, 2026, FDA's public records list Immucor GTI Diagnostics, Inc. with 2 510(k) clearances. The most recent is a 510(k) clearance dated Sep 11, 2020: PF4 Enhanced assay.
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.
| Sep 11, 2020 | PF4 Enhanced assayK201570 · LCO | 510(k) clearances |
| Jun 18, 2020 | PF4 IgG assayK201311 · LCO | 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
