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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name single (specified) analyte controls (assayed and unassayed)
510(k) Number K955468
Device Name OPUS PROLACTIN CONTROLS
Original Applicant
BEHRING DIAGNOSTICS, INC.
151 university ave.
westwood,  MA  02090
Original Contact nancy m johansen
Regulation Number862.1660
Classification Product Code
JJX  
Date Received11/30/1995
Decision Date 02/23/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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