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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
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 (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
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