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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 K993083
Device Name ALCYON 300I (WITH ISE MODULE) ANALYZER
Applicant
Abbott Laboratories
Dept. 09va Lc-2
1920 Hurd Dr.
Irving,  TX  75038
Applicant Contact MARK LITTLEFIELD
Correspondent
Abbott Laboratories
Dept. 09va Lc-2
1920 Hurd Dr.
Irving,  TX  75038
Correspondent Contact MARK LITTLEFIELD
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGZ   JGS  
Date Received09/15/1999
Decision Date 10/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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