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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
Device Name TETRACHROME REAGENTS AND TETRACXP SYSTEM
Applicant
BECKMAN COULTER, INC.
11800 SW 147TH AVE.
M/S 31-B06
MIAMI,  FL  33196 -2500
Applicant Contact NANCY NADLER
Correspondent
BECKMAN COULTER, INC.
11800 SW 147TH AVE.
M/S 31-B06
MIAMI,  FL  33196 -2500
Correspondent Contact NANCY NADLER
Regulation Number864.5220
Classification Product Code
OYE  
Date Received05/15/2012
Decision Date 07/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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