Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Denka Seiken Co., Ltd.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K161679 s LDL-EX SEIKENPYP2017-08-18 View
510(k) K060359 ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10JIT2006-04-14 View
510(k) K043264 LDL-EX SEIKEN ASSAY KITMRR2005-01-26 View
510(k) K041090 HDL-EX SEIKEN ASSAY KITLBS2004-10-29 View
510(k) K030546 CRP (II) CALIBRATORSJIS2003-06-02 View
510(k) K030545 CRP-LATEX (II)X2 SEIKEN ASSAY KITDCK2003-06-02 View
↑