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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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access tsh (3rd is) assay and access tsh (3rd is) calibrators on the access immunoassay systems BECKMAN COULTER, INC. K153651 08/18/2016
cortisol and cortisol calibrators on the access immunoassay systems BECKMAN COULTER, INC. K050202 02/09/2005
ck-mb and ck-mb calibrators on the access immunoassay systems, models 386371 and 386372 BECKMAN COULTER, INC. K030012 01/17/2003
access total t4 assay BECKMAN COULTER, INC. K023369 12/09/2002
access hypersensitive htsh assay BECKMAN COULTER, INC. K023093 11/25/2002
synchron systems c-reactive protein (c-rp) reagent; synchron systems cx c-rp calibrator BECKMAN COULTER, INC. K021572 07/19/2002
myoglobin and myoglobin calibrators on the access immunoassay systems, model 973243, 973244 BECKMAN COULTER, INC. K021229 06/28/2002
synchron systems direct ldl chloesterol reagent and calibrator BECKMAN COULTER, INC. K014103 01/28/2002
accutni and accutni calibrators on the access immunoassay system # 33340, 33345 BECKMAN COULTER, INC. K010429 06/05/2001
beckman coulter dnase b calibrator BECKMAN COULTER, INC. K010696 05/10/2001
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