Denka Seiken Co., Ltd. - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
Denka Seiken Co., Ltd. has 6 FDA 510(k) cleared medical devices. Based in Gosen City, Niigata, JP.
Historical record: 6 cleared submissions from 2003 to 2017. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Denka Seiken Co., Ltd. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Denka Seiken Co., Ltd.
6 devices
Cleared
Aug 18, 2017
s LDL-EX SEIKEN
Chemistry
427d
Cleared
Apr 14, 2006
ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10
Chemistry
60d
Cleared
Jan 26, 2005
LDL-EX SEIKEN ASSAY KIT
Chemistry
63d
Cleared
Oct 29, 2004
HDL-EX SEIKEN ASSAY KIT
Chemistry
186d
Cleared
Jun 02, 2003
CRP-LATEX (II)X2 SEIKEN ASSAY KIT
Immunology
102d
Cleared
Jun 02, 2003
CRP (II) CALIBRATORS
Immunology
102d