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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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