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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 K170160
Device Name Abbott ARCHITECT Free T3
Applicant
Abbott Laboratories
100 Abbott Park Rd., Dept. 09aa, Bldg. Ap08
Abbot Park,  IL  60064
Applicant Contact Linda Sohn
Correspondent
Abbott Laboratories
100 Abbott Park Rd., Dept. 09aa, Bldg. Ap08
Abbot Park,  IL  60064
Correspondent Contact Linda Sohn
Regulation Number862.1150
Classification Product Code
JIT  
Date Received01/18/2017
Decision Date 02/15/2017
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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