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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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PMA Number P940040 Center Devices Decision Date To 12/09/2016
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AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST Roche Molecular Systems, Inc. P940040 11/26/1996
ROCHE AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST Roche Molecular Systems, Inc. P940040 S001 09/12/2000
AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST Roche Molecular Systems, Inc. P940040 S003 04/22/2004
AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST Roche Molecular Systems, Inc. P940040 S004 06/23/2004
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST Roche Molecular Systems, Inc. P940040 S005 04/22/2005
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST Roche Molecular Systems, Inc. P940040 S006 12/14/2005
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST Roche Molecular Systems, Inc. P940040 S007 08/30/2007
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST Roche Molecular Systems, Inc. P940040 S008 01/11/2008
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST Roche Molecular Systems, Inc. P940040 S009 08/26/2008
AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST Roche Molecular Systems, Inc. P940040 S010 11/25/2008
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