Medical Device Manufacturer · US , Mchenry , IL

Biogenex Laboratories - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1981

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biogenex Laboratories Chemistry ✕

9 devices

1-9 of 9

Cleared Jan 06, 1993

PREGNAGEN 1-STEP PREGNANCY TEST

Chemistry · 85d

Cleared Jul 17, 1990

MODIFIED OVUGEN

Chemistry · 62d

Cleared Jan 13, 1989

Chemistry · 53d

Cleared Sep 09, 1988

Chemistry · 119d

Cleared Nov 23, 1987

OVUGEN SURETEST

Chemistry · 83d

Cleared Jun 02, 1983

RIAGEN B-HCG RIA KIT

Chemistry · 48d

Cleared May 21, 1982

RIAGEN B-HCG RIA

Chemistry · 23d

Cleared Apr 14, 1982

FLUOROGEN PAP FIA

Chemistry · 28d

Cleared Dec 17, 1981

Chemistry · 27d