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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Specific
510(k) Number K020845
Device Name EMIT 2000 VANCOMYCIN CALIBRATORS
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 Number862.3200
Classification Product Code
DLJ  
Date Received03/15/2002
Decision Date 05/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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