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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 K151566
Device Name Abbott ARCHITECT Total T4 Calibrators
Applicant
Abbott Laboratories
100 Abbott Park Rd. Dept. 09va, Ap08
Abbott Park,  IL  60064
Applicant Contact Lisa Lukowski
Correspondent
Abbott Laboratories
100 Abbott Park Rd. Dept. 09va, Ap08
Abbott Park,  IL  60064
Correspondent Contact Lisa Lukowski
Regulation Number862.1150
Classification Product Code
JIT  
Date Received06/10/2015
Decision Date 07/10/2015
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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