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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 K080468
Device Name LIASYS WITH MODELS LIASYS
Applicant
AMS S.R.L. ANALYZER MEDICAL SYSTEM
17/A VIA E. BARSANTI
GUIDONIA (ROME),  IT I-00012
Applicant Contact STEFANO CORRADI
Correspondent
AMS S.R.L. ANALYZER MEDICAL SYSTEM
17/A VIA E. BARSANTI
GUIDONIA (ROME),  IT I-00012
Correspondent Contact STEFANO CORRADI
Regulation Number862.1345
Classification Product Code
CFR  
Subsequent Product Codes
CDN   CEM   CGX   CGZ   CIT  
JGS   JJE  
Date Received02/21/2008
Decision Date 07/25/2008
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
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