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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode MTF PMA Number p Decision Date From 1/1/2014 Decision Date To 1/1/2015
 
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DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S026 09/25/2014
VIDAS TOTAL PSA (TPSA) ASSAY bioMerieux, Inc. P040008 S008 03/06/2014
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNO... BECKMAN COULTER, INC. P850048 S037 05/01/2014
ACCESS HYBRITECH PSA ASSAY BECKMAN COULTER, INC. P850048 S038 12/23/2014
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNO... BECKMAN COULTER, INC. P850048 S039 10/24/2014
ARCHITECT TOTAL PSA Abbott Laboratories P910007 S042 02/03/2014
ARCHITECT TOTAL PSA Abbott Laboratories P910007 S043 05/16/2014
ARCHITECT TOTAL PSA Abbott Laboratories P910007 S044 05/28/2014
ARCHITECT TOTAL PSA (LN 6C06) Abbott Laboratories P910007 S045 06/18/2014
ARCHITECT TOTAL PSA Abbott Laboratories P910007 S046 12/11/2014
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