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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K914958
Device Name RIATRAC PLUS
Applicant
Becton Dickinson Advanced Diagnostics
225 International Cir.
Cockeysville,  MD  21030
Applicant Contact LLOYD W.GAEDKE
Correspondent
Becton Dickinson Advanced Diagnostics
225 International Cir.
Cockeysville,  MD  21030
Correspondent Contact LLOYD W.GAEDKE
Regulation Number862.1660
Classification Product Code
JJY  
Date Received11/05/1991
Decision Date 03/18/1992
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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