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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 17 Results
ProductCode: JIS Applicant: BECKMAN COULTER, INC. Decision Date To: 04/23/2024
 
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synchron systems lipid calibrator BECKMAN COULTER, INC. K983640 12/21/1998
synchron systems direct ldl chloesterol reagent and calibrator BECKMAN COULTER, INC. K014103 01/28/2002
synchron systems c-reactive protein (c-rp) reagent; synchron systems cx c-rp calibrator BECKMAN COULTER, INC. K021572 07/19/2002
synchron lx systems prealbumin calibrator BECKMAN COULTER, INC. K994168 02/03/2000
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 cx systems microalbumin calibrator BECKMAN COULTER, INC. K994325 01/12/2000
myoglobin and myoglobin calibrators on the access immunoassay systems, model 973243, 973244 BECKMAN COULTER, INC. K021229 06/28/2002
immage immunochemistry system lipoprotein(a) lpax reagent, array system lipoprotein(a) lpa reagent, lipoprotein(a) calib BECKMAN COULTER, INC. K000121 05/17/2000
cortisol and cortisol calibrators on the access immunoassay systems BECKMAN COULTER, INC. K050202 02/09/2005
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