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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 K021381
Device Name MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
Applicant
Dade Behring, Inc.
514 Gbc Dr.
Newark,  DE  19702
Applicant Contact DONNA A WOLF
Correspondent
Dade Behring, Inc.
514 Gbc Dr.
Newark,  DE  19702
Correspondent Contact DONNA A WOLF
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/01/2002
Decision Date 06/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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