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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bathophenanthroline, Colorimetry, Iron (Non-Heme)
510(k) Number K873120
Device Name ABBOTT A-GENT IRON REAGENT KIT
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 Number862.1410
Classification Product Code
CFM  
Date Received08/10/1987
Decision Date 08/25/1987
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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