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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 K884821
Device Name ABBOTT SPECTRUM(R) BICARBONATE REAGENT
Applicant
Abbott Laboratories
1921 Hurd Dr.
P.O.Box 152020
Irving,  TX  75015 -2020
Applicant Contact BARBARA BOOKER
Correspondent
Abbott Laboratories
1921 Hurd Dr.
P.O.Box 152020
Irving,  TX  75015 -2020
Correspondent Contact BARBARA BOOKER
Regulation Number862.1160
Classification Product Code
KHS  
Date Received11/17/1988
Decision Date 12/27/1988
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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