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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
Original Applicant
INPECO S.P.A.
11 via g. di vittorio
segrate, milan,  IT 20090
Original 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 (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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