Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Denka Seiken'S — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011400 | MRSA-SCREEN | Denka Seiken'S | 2002-03-27 | 324 | 0 |
| K013359 | LP(A)-LATEX SEIKEN ASSAY KIT | Denka Seiken'S | 2002-03-08 | 149 | 0 |
| K011958 | CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT | Denka Seiken'S | 2001-12-04 | 165 | 0 |
| K981734 | VTEC-RPLA SEIKEN | Denka Seiken'S | 1998-09-22 | 127 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda