Medical Device Manufacturer · US , Minneapolis , MN

Kmi Diagnostics, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1997

Recent clearances: TESTOTERONE ELISA, 17 B-ESTRADIOL (ELISA), DHEA-S

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Kmi Diagnostics, Inc. Chemistry ✕

6 devices

1-6 of 6

Cleared Jan 29, 2002

Chemistry · 320d

Cleared May 11, 1999

Chemistry · 120d

Cleared Feb 24, 1998

TESTOTERONE ELISA

Chemistry · 133d

Cleared Nov 24, 1997

17 B-ESTRADIOL (ELISA)

Chemistry · 41d

Cleared Nov 13, 1997

Chemistry · 30d

Cleared Nov 13, 1997

PROGESTERONE ELISA

Chemistry · 30d