Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Merck KGaALabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record. See the Merck KGaA group view.
As of Nov 15, 2026, FDA's public records list Harleco with 116 510(k) clearances. The most recent is a 510(k) clearance dated Feb 12, 1982: ULTRAZYME PLUS GAMMA GT(65055-65056).
| Feb 12, 1982 | ULTRAZYME PLUS GAMMA GT(65055-65056)K820233 · JQB | 510(k) clearances |
| Dec 31, 1981 | ULTRACHEM GLUC-DHK813427 · LFR | 510(k) clearances |
| Nov 10, 1981 | ULTRACHEM CREA ITEM #64972K813043 · CGX | 510(k) clearances |
| Nov 10, 1981 | ULTRACHEM TP, ITEM #64974K813038 · CEK | 510(k) clearances |
| Nov 10, 1981 | ULTRACHEM GLUC-DH SET, ITEM #65048K813042 · LFR | 510(k) clearances |
| Nov 10, 1981 | ULTRACHEM E-CHOL, ITEM #65025K813039 · CHH | 510(k) clearances |
| Nov 10, 1981 | ULTRACHEM CA, ITEM #64975K813040 · CJY | 510(k) clearances |
| Nov 10, 1981 | ULTRAZYME-GT, ITEM #64959 & 65032K813041 · JQB | 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
