Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Meridian BioscienceLabelled 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 Meridian Bioscience Israel with 3 510(k) clearances. The most recent is a 510(k) clearance dated Dec 19, 2022: BreathID Hp System.
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.
| Dec 19, 2022 | BreathID Hp SystemK221896 · MSQ | 510(k) clearances |
| Nov 10, 2022 | BreathID® Smart SystemK223185 · MSQ | 510(k) clearances |
| Jun 23, 2022 | BreathID Hp Lab System, BreathID Smart SystemK220494 · MSQ | 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
