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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 K061879
Device Name SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM
Applicant
Hemodiagnostica, LLC
130 Gardeners Cir.
Johns Island,  SC  29455
Applicant Contact Bruno Borganti
Correspondent
Hemodiagnostica, LLC
130 Gardeners Cir.
Johns Island,  SC  29455
Correspondent Contact Bruno Borganti
Regulation Number862.1345
Classification Product Code
CFR  
Subsequent Product Codes
CDN   CEM   CGZ   JGS   JJE  
Date Received07/03/2006
Decision Date 12/15/2006
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
Predetermined Change
Control Plan Authorized		 No
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