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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Potassium
510(k) Number K093318
Device Name ACCELERATOR APS
Applicant
Abbott Laboratories
1920 Hurd Dr.
Lc-2, Ms 1-8
Irving,  TX  75038
Applicant Contact MARK LITTLEFIELD
Correspondent
Abbott Laboratories
1920 Hurd Dr.
Lc-2, Ms 1-8
Irving,  TX  75038
Correspondent Contact MARK LITTLEFIELD
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGZ   JGS   JJE   JQP  
Date Received10/23/2009
Decision Date 02/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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