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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 K130373
Device Name NAVIOS FLOW CYTOMETER SYSTEM
Applicant
Beckman Coulter, Inc.
11800 SW 147 Ave.
Miami,  FL  33196
Applicant Contact NANCY NADLER
Correspondent
Beckman Coulter, Inc.
11800 SW 147 Ave.
Miami,  FL  33196
Correspondent Contact NANCY NADLER
Regulation Number864.5220
Classification Product Code
OYE  
Subsequent Product Code
PDX  
Date Received02/14/2013
Decision Date 09/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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