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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K060371
Device Name THE EMIT 2000 TACROLIMUS CALIBRATORS
Applicant
Dade Behring, Inc.
P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact UK-TING LEWIS
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact UK-TING LEWIS
Regulation Number862.1150
Classification Product Code
JIT  
Date Received02/13/2006
Decision Date 03/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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