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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photometric Method, Magnesium
510(k) Number K173294
Device Name Magnesium
Applicant
Abbott Laboratories
1921 Hurd Dr.
Irving,  TX  75038
Applicant Contact Kimberly Senseman
Correspondent
Abbott Laboratories
1921 Hurd Dr.
Irving,  TX  75038
Correspondent Contact Kimberly Senseman
Regulation Number862.1495
Classification Product Code
JGJ  
Date Received10/16/2017
Decision Date 05/18/2018
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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