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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hexokinase, glucose
510(k) Number K131189
Device Name UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
Applicant
BECKMAN COULTER, INC.
250 S. KRAEMER ST
BREA,  CA  92821
Applicant Contact Yvette Lloyd
Correspondent
BECKMAN COULTER, INC.
250 S. KRAEMER ST
BREA,  CA  92821
Correspondent Contact Yvette Lloyd
Regulation Number862.1345
Classification Product Code
CFR  
Date Received04/26/2013
Decision Date 04/17/2014
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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