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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 28 Results
ProductCode: GKZ Applicant: BECKMAN COULTER, INC. Decision Date To: 10/01/2022
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itag mhc tetramer cmv assay BECKMAN COULTER, INC. K051122 08/01/2005
coulter lh 750 hematology analyzer BECKMAN COULTER, INC. K050057 02/10/2005
flowcare plg cd4 reagent BECKMAN COULTER, INC. K043215 01/19/2005
modification to coulter lh 500 hematology analyzer BECKMAN COULTER, INC. K042724 10/29/2004
coulter a t 5diff cap pierce (cp) BECKMAN COULTER, INC. K042173 10/12/2004
counter, differential cell: stemCXP System for the FC 500 with CXP Software Beckman Coulter, Inc. BK040055 09/16/2004
counter, differential cell: Stem-Kit Reagents Beckman Coulter, Inc. BK040032 05/05/2004
coulter lh 750 hematology analyzer BECKMAN COULTER, INC. K032342 09/26/2003
coulter lh 500 hematology analyzer BECKMAN COULTER, INC. K032000 08/13/2003
coulter act 5diff al hematology analyzer BECKMAN COULTER, INC. K032013 07/24/2003
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