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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Icn Biomedicals, Inc. · Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

99 daysmedian FDA review time
229 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K030211RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND Icn Biomedicals, Inc.2003-06-131430
K023252RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TESIcn Biomedicals, Inc.2002-11-22530
K926106IMMUCHEM PHE-MW EAIcn Biomedicals, Inc.1995-02-087970
K922944IMMUCHEM LH-MW ELISAIcn Biomedicals, Inc.1993-02-022290
K922376ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KITIcn Biomedicals, Inc.1992-10-051380
K922715IMMUCHEM PRL-MW ELISAIcn Biomedicals, Inc.1992-10-051220
K920442IMMUCHEM TSH-MW ELISAIcn Biomedicals, Inc.1992-03-18440
K913963IMMUCHEM NEONATAL TSH-MP ELISAIcn Biomedicals, Inc.1991-12-13990
K902445LYMPHO SEP(TM)Icn Biomedicals, Inc.1990-08-22820
K88519817-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIAIcn Biomedicals, Inc.1989-02-23690
K881005IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCGIcn Biomedicals, Inc.1988-05-27790

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda