FDA 510(k) Applications Submitted by DENKA SEIKEN CO., LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K161679 06/17/2016 s LDL-EX SEIKEN DENKA SEIKEN CO., LTD.
K060359 02/13/2006 ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 DENKA SEIKEN CO., LTD.
K030545 02/20/2003 CRP-LATEX (II)X2 SEIKEN ASSAY KIT DENKA SEIKEN CO., LTD.
K030546 02/20/2003 CRP (II) CALIBRATORS DENKA SEIKEN CO., LTD.
K041090 04/26/2004 HDL-EX SEIKEN ASSAY KIT DENKA SEIKEN CO., LTD.
K043264 11/24/2004 LDL-EX SEIKEN ASSAY KIT DENKA SEIKEN CO., LTD.


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