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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 K954144
Device Name OPUS HCG CONTROLS
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 Number862.1660
Classification Product Code
JJX  
Subsequent Product Code
JJT  
Date Received09/05/1995
Decision Date 10/06/1995
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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