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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 K113131
Device Name LIASYS 450
Applicant
Ams
17/A Via E. Barsanti
Guidonia, Rome,  IT I-00012
Applicant Contact STEFANO CORRADI
Correspondent
Ams
17/A Via E. Barsanti
Guidonia, Rome,  IT I-00012
Correspondent Contact STEFANO CORRADI
Regulation Number862.1345
Classification Product Code
CFR  
Subsequent Product Codes
CEM   CGZ   JGS   JJE  
Date Received10/24/2011
Decision Date 03/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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