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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic, Carbon-Dioxide
510(k) Number K981840
Device Name CO2
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 Number862.1160
Classification Product Code
KHS  
Date Received05/26/1998
Decision Date 06/08/1998
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
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