Medical Device Manufacturer · US , Carson , CA

Icn Biomedicals, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1988

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Icn Biomedicals, Inc. Chemistry ✕

8 devices

1-8 of 8

Cleared Feb 08, 1995

IMMUCHEM PHE-MW EA

Chemistry · 797d

Cleared Feb 02, 1993

IMMUCHEM LH-MW ELISA

Chemistry · 229d

Cleared Oct 05, 1992

ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT

Chemistry · 138d

Cleared Oct 05, 1992

IMMUCHEM PRL-MW ELISA

Chemistry · 122d

Cleared Mar 18, 1992

IMMUCHEM TSH-MW ELISA

Chemistry · 44d

Cleared Dec 13, 1991

IMMUCHEM NEONATAL TSH-MP ELISA

Chemistry · 99d

Cleared Feb 23, 1989

17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA

Chemistry · 69d

Cleared May 27, 1988

IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG

Chemistry · 79d