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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Free Thyroxine
510(k) Number K073604
Device Name DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD
Applicant
Dade Behring, Inc.
500 Gbc Dr., Mailstop 514
Newark,  DE  19714 -6101
Applicant Contact YUK-TING LEWIS
Correspondent
Dade Behring, Inc.
500 Gbc Dr., Mailstop 514
Newark,  DE  19714 -6101
Correspondent Contact YUK-TING LEWIS
Regulation Number862.1695
Classification Product Code
CEC  
Subsequent Product Codes
JIT   JJE  
Date Received12/21/2007
Decision Date 03/13/2008
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
Recalls CDRH Recalls
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