Medical Device Manufacturer · US , East Stroudsburg , PA

Ibl GmbH - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2003

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ibl GmbH Chemistry ✕

4 devices

1-4 of 4

Cleared Oct 03, 2005

TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE)

Chemistry · 75d

Cleared Sep 24, 2004

LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM

Chemistry · 127d

Cleared Jul 22, 2004

LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA

Chemistry · 105d

Cleared Feb 27, 2004

LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND...

Chemistry · 85d