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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igg, Antigen, Antiserum, Control
510(k) Number K943997
Device Name BEHRING NEPHELOMETER II
Applicant
Behring Diagnostics, Inc.
151 University Ave.
Westwood,  MA  02090
Applicant Contact NANCY M JOHANSEN
Correspondent
Behring Diagnostics, Inc.
151 University Ave.
Westwood,  MA  02090
Correspondent Contact NANCY M JOHANSEN
Regulation Number866.5510
Classification Product Code
DEW  
Subsequent Product Codes
CFQ   CZP   DCH   GTQ  
Date Received08/16/1994
Decision Date 10/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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