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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biuret (Colorimetric), Total Protein
510(k) Number K860426
Device Name A-GENT LIQUID TOTAL PROTEIN
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 Number862.1635
Classification Product Code
CEK  
Date Received02/04/1986
Decision Date 04/03/1986
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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