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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Luteinizing Hormone
510(k) Number K962866
Device Name OPUS HLH
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 Number862.1485
Classification Product Code
CEP  
Date Received07/23/1996
Decision Date 08/23/1996
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
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