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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K032697
Device Name DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
Applicant
Dade Behring, Inc.
Glasgow Business Community
P.O. Box 6101, Bldg. 500
Newark,  DE  19714
Applicant Contact LORRAINE H PIESTRAK
Correspondent
Dade Behring, Inc.
Glasgow Business Community
P.O. Box 6101, Bldg. 500
Newark,  DE  19714
Correspondent Contact LORRAINE H PIESTRAK
Regulation Number862.1150
Classification Product Code
JIS  
Date Received09/02/2003
Decision Date 11/07/2003
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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