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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Follicle-Stimulating Hormone
510(k) Number K922376
Device Name ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT
Applicant
Icn Biomedicals, Inc.
3300 Hyland Ave.
Costa Mesa,  CA  92626
Applicant Contact SUSANNE J GRAVES
Correspondent
Icn Biomedicals, Inc.
3300 Hyland Ave.
Costa Mesa,  CA  92626
Correspondent Contact SUSANNE J GRAVES
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received05/20/1992
Decision Date 10/05/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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