Denka Seiken Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K161679s LDL-EX SEIKENAugust 18, 2017
K060359ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10April 14, 2006
K043264LDL-EX SEIKEN ASSAY KITJanuary 26, 2005
K041090HDL-EX SEIKEN ASSAY KITOctober 29, 2004
K030546CRP (II) CALIBRATORSJune 2, 2003
K030545CRP-LATEX (II)X2 SEIKEN ASSAY KITJune 2, 2003