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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
510(k) Number K926106
Device Name IMMUCHEM PHE-MW EA
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 Number862.1555
Classification Product Code
JNB  
Date Received12/03/1992
Decision Date 02/08/1995
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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