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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 K012468
Device Name MODIFICATION TO N/T PROTEIN CONTROL SL
Applicant
Dade Behring, Inc.
Glasgow Site, P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact REBECCA S AYASH
Correspondent
Dade Behring, Inc.
Glasgow Site, P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact REBECCA S AYASH
Regulation Number862.1660
Classification Product Code
JJY  
Date Received08/02/2001
Decision Date 09/04/2001
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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