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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode measurement, blood-gases (pco2, po2) and blood ph
510(k) Number K963800
Device Name IL SYNTHESIS
Applicant
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
LEXINGTON,  MA  02173
Applicant Contact BETTY J LANE
Correspondent
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
LEXINGTON,  MA  02173
Correspondent Contact BETTY J LANE
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GFK   GLY  
JFP   JGS  
Date Received09/23/1996
Decision Date 11/13/1996
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
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