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 Denka CompanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Denka Seiken with 10 510(k) clearances. The most recent is a 510(k) clearance dated Aug 18, 2017: s LDL-EX SEIKEN.
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.
| Aug 18, 2017 | s LDL-EX SEIKENK161679 · PYP | 510(k) clearances |
| Apr 14, 2006 | ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10K060359 · JIT | 510(k) clearances |
| Jan 26, 2005 | LDL-EX SEIKEN ASSAY KITK043264 · MRR | 510(k) clearances |
| Oct 29, 2004 | HDL-EX SEIKEN ASSAY KITK041090 · LBS | 510(k) clearances |
| Jun 2, 2003 | CRP-LATEX (II)X2 SEIKEN ASSAY KITK030545 · DCK | 510(k) clearances |
| Jun 2, 2003 | CRP (II) CALIBRATORSK030546 · JIS | 510(k) clearances |
| Mar 27, 2002 | MRSA-SCREENK011400 · MYI | 510(k) clearances |
| Mar 8, 2002 | LP(A)-LATEX SEIKEN ASSAY KITK013359 · DFC | 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
