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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 28 Results
ProductCode: GKZ Applicant: BECKMAN COULTER, INC. Decision Date To: 10/01/2022
 
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coulter hmx analyzer, model 6605523, coulter hmx with autoloader, model 6605526 BECKMAN COULTER, INC. K010765 04/13/2001
coulter lh 750 hematology analyzer, model 6605632 BECKMAN COULTER, INC. K011342 07/09/2001
counter, differential cell: stemONE System for EPICS XL/ XL-MCL Flow Cytometry Systems Beckman Coulter, Inc. BK010044 05/20/2002
modification to coulter lh 750 hematology analyzer, model 6605632 BECKMAN COULTER, INC. K022161 07/29/2002
coulter act 5diff al hematology analyzer BECKMAN COULTER, INC. K032013 07/24/2003
coulter act 5diff autoloader (al) BECKMAN COULTER, INC. K030291 04/17/2003
coulter lh 500 hematology analyzer BECKMAN COULTER, INC. K032000 08/13/2003
coulter lh 750 body fluids application BECKMAN COULTER, INC. K030606 04/21/2003
coulter lh 750 hematology analyzer BECKMAN COULTER, INC. K032342 09/26/2003
cyto-stat tetrachrome cd45-fit/cd4-pe/cd3-pc5 monoclonal antibody reagent, cyto-stat tetrachrom cd45-fitc/cd56-pe/cd19-a BECKMAN COULTER, INC. K030408 03/04/2003
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