Denka Seiken Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Denka Seiken Co., Ltd.” (first 2003, latest 2017), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 102 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 427 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Denka Seiken Co., Ltd. took a median 427 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 70 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| JIS | Calibrator, Primary | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | 1 |
| MRR | System, Test, Low Density, Lipoprotein | 1 | 1 |
| PYP | Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test | 1 | 1 |
Review panels
- Clinical Chemistry (5)
- Immunology (1)
Most recent Denka Seiken Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161679 | s LDL-EX SEIKEN | PYP | 2017-08-18 | 427 |
| K060359 | ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 | JIT | 2006-04-14 | 60 |
| K043264 | LDL-EX SEIKEN ASSAY KIT | MRR | 2005-01-26 | 63 |
| K041090 | HDL-EX SEIKEN ASSAY KIT | LBS | 2004-10-29 | 186 |
| K030546 | CRP (II) CALIBRATORS | JIS | 2003-06-02 | 102 |
| K030545 | CRP-LATEX (II)X2 SEIKEN ASSAY KIT | DCK | 2003-06-02 | 102 |
Recalls
openFDA lists no recalls under a recalling firm named Denka Seiken Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Denka Seiken'S (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Denka Seiken Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Denka Seiken Co., Ltd.” (first 2003, latest 2017), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Denka Seiken Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Denka Seiken Co., Ltd. is 102 days.
Which FDA product codes appear under Denka Seiken Co., Ltd.?
The most frequent FDA product codes under this applicant name are DCK (C-Reactive Protein, Antigen, Antiserum, And Control, 1); JIS (Calibrator, Primary, 1); JIT (Calibrator, Secondary, 1).
Next steps
- See all 6 Denka Seiken Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DCK, Denka Seiken Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.