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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
510(k) Number K130253
Device Name TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION
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 Number862.2750
Classification Product Code
PER  
Date Received02/01/2013
Decision Date 07/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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