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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 K935069
Device Name IL1430 BGELECTROLYTE ANALYZER
Applicant
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730
Applicant Contact WALLIS W CADY
Correspondent
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730
Correspondent Contact WALLIS W CADY
Regulation Number862.1120
Classification Product Code
CHL  
Date Received10/25/1993
Decision Date 03/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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