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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 13 Results
productcode MAQ PMA Number p Decision Date From 1/1/2011 Decision Date To 1/1/2012
 
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COBAS HPV TEST Roche Molecular Systems, Inc. P100020 S001 12/29/2011
CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION HOLOGIC, INC. P080014 S007 12/12/2011
CERVISTA HPV HR COMPONENTS HOLOGIC, INC. P080014 S009 08/02/2011
CERVISTA HPV 16/18 HOLOGIC, INC. P080015 S005 08/02/2011
CERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR... HOLOGIC, INC. P080014 S008 06/23/2011
CERVISTA HUMAN PAPILLOMA VIRUS (HPV) 16/18 HOLOGIC, INC. P080015 S004 06/23/2011
DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGEN... QIAGEN GAITHERSBURG, INC P890064 S026 04/20/2011
COBAS HPV TEST Roche Molecular Systems, Inc. P100020 04/19/2011
CERVISTA HPV HR HOLOGIC, INC. P080014 S005 03/29/2011
CERVISTA HPV 16/18 HOLOGIC, INC. P080015 S002 03/29/2011
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