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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Potassium
510(k) Number K121012
Device Name FLEXLAB 3.6, ACCELERATOR A3600
Applicant
Inpeco S.P.A.
11 Via G. Di Vittorio
Segrate, Milan,  IT 20090
Applicant Contact ROBERTO TAMBORRA
Correspondent
Inpeco S.P.A.
11 Via G. Di Vittorio
Segrate, Milan,  IT 20090
Correspondent Contact ROBERTO TAMBORRA
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGZ   JGS   JJE   JQP  
Date Received04/03/2012
Decision Date 08/31/2012
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
Recalls CDRH Recalls
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