Denka Seiken Co., Ltd.
Gosen City, Niigata, JP
Denka Seiken Co., Ltd. appears in FDA device records in Gosen City, Niigata, JP. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 6
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 6 510(k) clearances for Denka Seiken Co., Ltd. between 2003 and 2017. The busiest year on record is 2003, with 2. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K161679 | s LDL-EX SEIKEN | PYP | Substantially Equivalent | |
| K060359 | ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 | JIT | Substantially Equivalent | |
| K043264 | LDL-EX SEIKEN ASSAY KIT | MRR | Substantially Equivalent | |
| K041090 | HDL-EX SEIKEN ASSAY KIT | LBS | Substantially Equivalent | |
| K030546 | CRP (II) CALIBRATORS | JIS | Substantially Equivalent | |
| K030545 | CRP-LATEX (II)X2 SEIKEN ASSAY KIT | DCK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain