Medical Device Manufacturer · JP , Tokyo

Denka Seiken'S - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1998

Recent clearances: MRSA-SCREEN, LP(A)-LATEX SEIKEN ASSAY KIT, CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Denka Seiken'S Chemistry ✕

2 devices

1-2 of 2

Cleared Mar 08, 2002

LP(A)-LATEX SEIKEN ASSAY KIT

Chemistry · 149d

Cleared Dec 04, 2001

CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT

Chemistry · 165d