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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K170317
Device Name Alinity i Total ß-hCG Reagent Kit, Alinity i System
Applicant
ABBOTT LABORATORIES
DEPT. 09AA, BLDG AP8
100 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064
Applicant Contact LINDA SOHN
Correspondent
ABBOTT LABORATORIES
DEPT. 09AA, BLDG AP8
100 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064
Correspondent Contact LINDA SOHN
Regulation Number862.1155
Classification Product Code
DHA  
Subsequent Product Code
JJE  
Date Received02/01/2017
Decision Date 10/23/2017
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
Recalls CDRH Recalls
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