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U.S. Department of Health and Human Services

510(k) Premarket Notification
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11 to 17 of 17 Results
ProductCode: JIS Applicant: BECKMAN COULTER, INC. Decision Date To: 04/23/2024
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immage immunochemistry system lipoprotein(a) lpax reagent, array system lipoprotein(a) lpa reagent, lipoprotein(a) calib BECKMAN COULTER, INC. K000121 05/17/2000
access ostase immunoenzymetric assay BECKMAN COULTER, INC. K994278 03/28/2000
synchron lx systems microalbumin calibrator BECKMAN COULTER, INC. K000331 02/10/2000
synchron cx systems prealbumin calibrator BECKMAN COULTER, INC. K994169 02/03/2000
synchron lx systems prealbumin calibrator BECKMAN COULTER, INC. K994168 02/03/2000
synchron cx systems microalbumin calibrator BECKMAN COULTER, INC. K994325 01/12/2000
synchron systems lipid calibrator BECKMAN COULTER, INC. K983640 12/21/1998
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