• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
1 to 9 of 9 Results
productcode OWD PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
New Search  
Export all 9 Records to ExcelExport to Excel HelpHelp
Device
Sort by Device [A-Z]
Sort by Device [Z-A]
Applicant
Sort by Applicant [A-Z]
Sort by Applicant [Z-A]
PMA
Number
Sort by PMA Number [0-9]
Sort by PMA Number [9-0]
Decision
Date
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
cobas® ezh2 mutation test Roche Molecular System, Inc. P200014 06/18/2020
cobas kras mutation test Roche Molecular Systems, Inc. P140023 S022 05/18/2020
leukostrat cdx flt3 mutation assay INVIVOSCRIBE TECHNOLOGIES, INC P160040 S006 05/14/2020
therascreen braf v600e rgq pcr kit QIAGEN GmbH P190026 04/15/2020
therascreen kras rgq pcr kit QIAGEN GmbH P110027 S011 04/03/2020
therascreen egfr rgq pcr kit QIAGEN GmbH P120022 S021 04/03/2020
therascreen fgfr rgq pcr kit QIAGEN GmbH P180043 S002 04/03/2020
therascreen pik3ca rgq pcr kit QIAGEN GMBH P190001 S001 04/03/2020
thxid-braf assay kit bioMerieux, Inc. P120014 S010 02/26/2020
-
-