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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 of 78 Results
PMA Number P050028 Center Devices Decision Date To 08/23/2019
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cobas ampliprep/cobas taqman hbv test, v2.0 and co... Roche Molecular Systems, Inc. P050028 S072 12/13/2018
cobas ampliprep/cobas taqman hbv test, v2.0 and co... Roche Molecular Systems, Inc. P050028 S071 12/07/2018
cobas ampliprep/cobas taqman hbv test, v2.0 and co... Roche Molecular Systems, Inc. P050028 S070 09/19/2018
roche cobas ampliprep/cobas taqman hbv test, v2.0 ... Roche Molecular Systems, Inc. P050028 S069 08/17/2018
cobas taqman hbv test for use with the high pure s... Roche Molecular Systems, Inc. P050028 S068 07/26/2018
cobas taqman hbv test for use with the high pure s... Roche Molecular Systems, Inc. P050028 S067 07/05/2018
cobas taqman hbv test, high pure system viral nucl... Roche Molecular Systems, Inc. P050028 S066 07/03/2018
roche cbas taqman hbv test, v2.0 Roche Molecular Systems, Inc. P050028 S065 06/14/2018
cobas ampliprep/cobas taqman hbv test, v2.0 Roche Molecular Systems, Inc. P050028 S062 05/15/2018
cobas ampliprep/cobas taqman hbv test, v2.0 Roche Molecular Systems, Inc. P050028 S064 05/15/2018
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