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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K122398
Model 10491447 / 1049148 / 10491449 / 10341179
Device Name RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
Original Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC.
2 edgewater drive
norwood,  MA  02062
Original Contact noor malki
Regulation Number862.1150
Classification Product Code
JIX  
Date Received08/07/2012
Decision Date 10/12/2012
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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