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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K913963
Device Name IMMUCHEM NEONATAL TSH-MP ELISA
Applicant
Icn Biomedicals, Inc.
3300 Hyland Ave.
Costa Mesa,  CA  92626
Applicant Contact JEFFREY C TRAVIS
Correspondent
Icn Biomedicals, Inc.
3300 Hyland Ave.
Costa Mesa,  CA  92626
Correspondent Contact JEFFREY C TRAVIS
Regulation Number862.1690
Classification Product Code
JLW  
Date Received09/05/1991
Decision Date 12/13/1991
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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