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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name urease and glutamic dehydrogenase, urea nitrogen
510(k) Number K981918
Device Name UREA
Applicant
ABBOTT LABORATORIES
DEPT. 09VA LC-2
1920 HURD DRIVE
IRVING,  TX  75038
Applicant Contact MARK LITTLEFIELD
Correspondent
ABBOTT LABORATORIES
DEPT. 09VA LC-2
1920 HURD DRIVE
IRVING,  TX  75038
Correspondent Contact MARK LITTLEFIELD
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received06/01/1998
Decision Date 07/28/1998
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
Recalls CDRH Recalls
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