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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name flow cytometric reagents and accessories.
510(k) Number K121445
Model 629638, 6607013, 6607073
Device Name TETRACHROME REAGENTS AND TETRACXP SYSTEM
Original Applicant
BECKMAN COULTER, INC.
11800 sw 147th ave.
m/s 31-b06
miami,  FL  33196 2500
Original Contact nancy nadler
Regulation Number864.5220
Classification Product Code
OYE  
Date Received05/15/2012
Decision Date 07/26/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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