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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 K981799
Device Name CREA
Applicant
Abbott Laboratories
1920 Hurd Dr.
Irving,  TX  75038
Applicant Contact MARK LITTLEFIELD
Correspondent
Abbott Laboratories
1920 Hurd Dr.
Irving,  TX  75038
Correspondent Contact MARK LITTLEFIELD
Regulation Number862.1225
Classification Product Code
CGX  
Date Received05/21/1998
Decision Date 07/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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