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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 K962694
Device Name OPUS B12 CONTROLS
Applicant
Behring Diagnostics, Inc.
151 University Ave.
Westwood,  MA  02090
Applicant Contact RUTH C FORSTADT
Correspondent
Behring Diagnostics, Inc.
151 University Ave.
Westwood,  MA  02090
Correspondent Contact RUTH C FORSTADT
Regulation Number862.1660
Classification Product Code
JJX  
Date Received07/11/1996
Decision Date 07/22/1996
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
Predetermined Change
Control Plan Authorized		 No
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