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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, Chloride
510(k) Number K980367
Device Name AEROSET SYSTEM
Applicant
ABBOTT LABORATORIES
1920 HURD DRIVE
IRVING,  TX  75038
Applicant Contact ANDREW JOHNSON
Correspondent
ABBOTT LABORATORIES
1920 HURD DRIVE
IRVING,  TX  75038
Correspondent Contact ANDREW JOHNSON
Regulation Number862.1170
Classification Product Code
CGZ  
Subsequent Product Codes
CEM   JGS   JJE  
Date Received01/29/1998
Decision Date 04/01/1998
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
Recalls CDRH Recalls
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