Icn Biomedicals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K030211RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016June 13, 2003
K023252RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020November 22, 2002
K926106IMMUCHEM PHE-MW EAFebruary 8, 1995
K922944IMMUCHEM LH-MW ELISAFebruary 2, 1993
K922715IMMUCHEM PRL-MW ELISAOctober 5, 1992
K922376ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KITOctober 5, 1992
K920442IMMUCHEM TSH-MW ELISAMarch 18, 1992
K913963IMMUCHEM NEONATAL TSH-MP ELISADecember 13, 1991
K902445LYMPHO SEP(TM)August 22, 1990
K88519817-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIAFebruary 23, 1989
K881005IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCGMay 27, 1988