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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 7 of 7 Results
productcode MTG PMA Number p Decision Date From 1/1/2008 Decision Date To 1/1/2009
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Device
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Applicant
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PMA
Number
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Decision
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IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA SIEMENS MEDICAL SOLUTIONS DIAG P060005 S001 12/30/2008
ELECSYS FREE PSA TEST SYSTEM ON COBAS E 601 IMMUNO... ROCHE DIAGNOSTICS CORP. P000027 S006 10/17/2008
ELECSYS FREE PSA ROCHE DIAGNOSTICS CORP. P000027 S007 09/17/2008
ACCESS HYBRITECH FREE PSA ASSAY BECKMAN COULTER, INC. P970038 S012 08/13/2008
DIMENSION FPSA FLEX REAGENT SIEMENS HEALTHCARE DIAGNOSTICS P020027 S008 03/14/2008
DIMENSION FPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P020027 S007 03/13/2008
ACCESS HYBRITECT FREE PSA BECKMAN COULTER, INC. P970038 S011 03/06/2008
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