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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name acid, lactic, enzymatic method
510(k) Number K112430
Device Name I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
Applicant
ABBOTT PONT OF CARE INC
400 COLLEGE ROAD EAST
PRINCETON,  NJ  08540
Applicant Contact YUKO HARTLEY
Correspondent
ABBOTT PONT OF CARE INC
400 COLLEGE ROAD EAST
PRINCETON,  NJ  08540
Correspondent Contact YUKO HARTLEY
Regulation Number862.1450
Classification Product Code
KHP  
Date Received08/24/2011
Decision Date 12/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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