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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 K992834
Device Name GEM PREMIER 3000
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 Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   GKF   JFO   JGS  
Date Received08/23/1999
Decision Date 11/24/1999
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
Recalls CDRH Recalls
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