Medical Device Manufacturer · US , Seattle , WA

Mitsubishi Kagaku Iatron - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2008

Recent clearances: PATHFAST CK-MB-II, PATHFAST MYO-II, PATHFAST D-DIMER, PATHFAST HSCRP

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mitsubishi Kagaku Iatron Chemistry ✕

3 devices

1-3 of 3

Cleared Aug 17, 2009

PATHFAST CK-MB-II, PATHFAST MYO-II

Chemistry · 459d

Cleared Mar 09, 2009

Chemistry · 111d

Cleared Feb 05, 2008

PATHFAST NTPROBNP AND D-DIMER TESTS

Chemistry · 183d