|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
GSP Neonatal Creatine Kinase - MM kit
|
PerkinElmer Inc. |
DEN180056 |
|
12/12/2019 |
cobas vivoDx MRSA
|
Roche Molecular Systems, Inc. |
DEN190016 |
|
12/05/2019 |
WOUNDCHEK Bacterial Status
|
Alere Scarborough, Inc. |
DEN180014 |
|
12/02/2019 |
EchoTip Insight Portosystemic Pressure G
|
Cook Ireland Ltd. |
DEN180062 |
|
11/20/2019 |
Sentosa SQ HIV Genotyping Assay
|
Vela Diagnostics USA Inc |
BR190330 |
|
11/05/2019 |
OraQuick Ebola Rapid Antigen Test
|
OraSure Technologies, Inc. |
DEN190025 |
|
10/10/2019 |
IB-Stim
|
Innovative Health Solutions (IHS), Inc. |
DEN180057 |
|
06/07/2019 |
Synovasure Alpha Defensin Lateral Flow T
|
CD Diagnostics Inc. |
DEN180032 |
|
05/23/2019 |
ZIKV Detect 2.0 IgM Capture ELISA
|
InBios International, Inc. |
DEN180069 |
|
05/23/2019 |
Nerivio Migra
|
Theranica Bioelectronics ltd |
DEN180059 |
|
05/20/2019 |