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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 K980757
Device Name ILAB 600 CLINICAL CHEMISTRY SYSTEM
Applicant
Instrumentation Laboratory CO
113 Hartwell Ave.
Lexington,  MA  02173
Applicant Contact CAROL MARBLE
Correspondent
Instrumentation Laboratory CO
113 Hartwell Ave.
Lexington,  MA  02173
Correspondent Contact CAROL MARBLE
Regulation Number862.1170
Classification Product Code
CGZ  
Subsequent Product Codes
CEK   CEM   CFJ   CFR   CGA  
CGS   CGX   CIC   CIG   CIT   CIX  
CJE   CKB   DIH   JFJ   JGJ   JGS  
JIX   JJW   JJX   JJY   KHS  
Date Received02/27/1998
Decision Date 04/21/1998
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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