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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 12 Results
productcode MAQ PMA Number p Decision Date From 1/1/2013 Decision Date To 1/1/2014
 
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PMA
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COBAS HPV TEST, 240 TESTS; COBAS HPV TEST 960 TEST... Roche Molecular Systems, Inc. P100020 S012 12/16/2013
CERVISTA HPV HR HOLOGIC, INC. P080014 S020 12/03/2013
CERVISTA HPV 16/18 HOLOGIC, INC. P080015 S011 12/03/2013
COBAS HPV TEST Roche Molecular Systems, Inc. P100020 S011 09/12/2013
COBAS HPV TEST Roche Molecular Systems, Inc. P100020 S010 09/06/2013
CERVISTA HPV HR ASSAY HOLOGIC, INC. P080014 S017 08/22/2013
COBAS HPV TEST Roche Molecular Systems, Inc. P100020 S009 08/21/2013
ROCHE COBAS HPV TEST Roche Molecular Systems, Inc. P100020 S004 06/25/2013
CERVISTA HPV HR, GENFIND DNA EXTRACTION KIT HOLOGIC, INC. P080014 S015 04/18/2013
CERVISTA HPV HR ASSAY HOLOGIC, INC. P080014 S016 03/15/2013
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