Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Sekisui ChemicalLabelled 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 Sekisui Medical Co., Ltd. with 1 510(k) clearance. The most recent is a 510(k) clearance dated May 9, 2018: CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set.
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.
| Date | Record | Source |
|---|---|---|
| May 9, 2018 | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control SetK173202 · JPA | 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
