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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 42 Results
PMA Number P970038 Decision Date To 05/12/2024
 
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TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-M... BECKMAN COULTER, INC. P970038 03/10/1998
TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-M... BECKMAN COULTER, INC. P970038 S001 09/24/1998
TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY BECKMAN COULTER, INC. P970038 S002 06/16/1999
TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY BECKMAN COULTER, INC. P970038 S003 06/16/1999
ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT BECKMAN COULTER, INC. P970038 S004 02/24/2000
ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOAS... BECKMAN COULTER, INC. P970038 S005 11/27/2002
ACCESS HYBRITECH FREE PSA ON THE SYNCHRON LXI 725 ... BECKMAN COULTER, INC. P970038 S006 01/09/2003
ACCESS HYBRITECH FREE PSA ON THE UNICEL DXI 800 AC... BECKMAN COULTER, INC. P970038 S007 02/28/2003
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS I... BECKMAN COULTER, INC. P970038 S008 05/18/2006
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS I... BECKMAN COULTER, INC. P970038 S009 09/19/2007
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