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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 13 Results
ProductCode: JJX Applicant: BECKMAN COULTER, INC. Decision Date To: 05/23/2024
 
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access hybritech p2psa qc on the access immunoassay systems BECKMAN COULTER, INC. K112603 11/04/2011
access sex hormone binding globulin reagent, access sex hormone binding globulin calibrators and access sex hormone bind BECKMAN COULTER, INC. K083867 08/27/2009
access stfr, access stfr calibrators, and access stfr qc with models, a32493, a32494, and a32495 BECKMAN COULTER, INC. K080634 08/11/2008
inhibin a calibrators & controls on the access immunoassay systems BECKMAN COULTER, INC. K070144 02/01/2007
instrinsic factor ab, calibrators, and qc on the access immunoassay systems, models 387992, 387993, 387999 BECKMAN COULTER, INC. K033603 12/19/2003
vigil dnase b control BECKMAN COULTER, INC. K010693 04/11/2001
accutni qc on the access immunoassay system #33349 BECKMAN COULTER, INC. K010428 03/13/2001
synchron control BECKMAN COULTER, INC. K001458 06/02/2000
access hybritech psa qc, model 37209 BECKMAN COULTER, INC. K994200 01/18/2000
access ostase qc BECKMAN COULTER, INC. K994277 01/14/2000
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