ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT

Radioimmunoassay, Follicle-stimulating Hormone

ICN BIOMEDICALS, INC.

The following data is part of a premarket notification filed by Icn Biomedicals, Inc. with the FDA for Icn Biomedicals Immuchem(tm) Fsh-mw Elisa Kit.

Pre-market Notification Details

Device IDK922376
510k NumberK922376
Device Name:ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT
ClassificationRadioimmunoassay, Follicle-stimulating Hormone
Applicant ICN BIOMEDICALS, INC. 3300 HYLAND AVE. Costa Mesa,  CA  92626
ContactSusanne J Graves
CorrespondentSusanne J Graves
ICN BIOMEDICALS, INC. 3300 HYLAND AVE. Costa Mesa,  CA  92626
Product CodeCGJ  
CFR Regulation Number862.1300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-20
Decision Date1992-10-05

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