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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 K141932
Device Name AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
Applicant
BECKMAN COULTER, INC.
11800 SW 147TH AVE
MIAMI,  FL  33196
Applicant Contact ANTHONY DENNIS
Correspondent
BECKMAN COULTER, INC.
11800 SW 147TH AVE
MIAMI,  FL  33196
Correspondent Contact ANTHONY DENNIS
Regulation Number864.5220
Classification Product Code
OYE  
Subsequent Product Code
JPK  
Date Received07/16/2014
Decision Date 04/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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