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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 K872311
Device Name ABBOTT A-GENT LIQUID MAGNESIUM REAGENT
Applicant
Abbott Laboratories
1921 Hurd Dr.
P.O.Box 152020
Irving,  TX  75015
Applicant Contact KEITH MINTER
Correspondent
Abbott Laboratories
1921 Hurd Dr.
P.O.Box 152020
Irving,  TX  75015
Correspondent Contact KEITH MINTER
Regulation Number862.1495
Classification Product Code
JGJ  
Date Received06/17/1987
Decision Date 07/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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