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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 K944202
Device Name ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED
Applicant
Abbott Laboratories
Dept: 09v8 Bldg: Ap5-2
100 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact Irene Powers
Correspondent
Abbott Laboratories
Dept: 09v8 Bldg: Ap5-2
100 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact Irene Powers
Regulation Number862.1495
Classification Product Code
JGJ  
Date Received08/11/1994
Decision Date 11/14/1994
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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