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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K083809
Device Name CREATININE
Applicant
Abbott Laboratories
1921 Hurd Dr.
Irving,  TX  75038
Applicant Contact LINDA MORRIS
Correspondent
Abbott Laboratories
1921 Hurd Dr.
Irving,  TX  75038
Correspondent Contact LINDA MORRIS
Regulation Number862.1225
Classification Product Code
CGX  
Date Received12/22/2008
Decision Date 04/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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