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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, secondary
510(k) Number K120591
Models TB-20270477D, TB-20270478D, TB-20270480D
Device Name DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2
Original Applicant
DIAMOND DIAGNOSTICS, INC
333 fiske st
holliston,  MA  01746
Original Contact kathy cruz
Regulation Number862.1150
Classification Product Code
JIT  
Date Received02/28/2012
Decision Date 04/17/2012
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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