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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
510(k) Number K964764
Device Name OPUS BONE ALP
Applicant
BEHRING DIAGNOSTICS, INC.
151 UNIVERSITY AVE.
WESTWOOD,  MA  02090
Applicant Contact Ruth Forstadt
Correspondent
BEHRING DIAGNOSTICS, INC.
151 UNIVERSITY AVE.
WESTWOOD,  MA  02090
Correspondent Contact Ruth Forstadt
Regulation Number862.1050
Classification Product Code
CIN  
Date Received11/27/1996
Decision Date 01/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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