|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
Aptima Mycoplasma genitalium Assay
|
Hologic, Inc. |
DEN180047 |
|
01/23/2019 |
EyeBOX
|
Oculogica, Inc. |
DEN170091 |
|
12/28/2018 |
MLL (KMT2A) Breakapart FISH Probe Kit; A
|
Cytocell Ltd |
DEN170070 |
|
12/21/2018 |
Miris Human Milk Analyzer
|
Miris AB |
DEN180007 |
|
12/21/2018 |
SEM Scanner (Model 200)
|
Bruin Biometrics, LLC |
DEN170021 |
|
12/20/2018 |
Enlight 1810
|
Timpel Inc. |
DEN170072 |
|
12/20/2018 |
Retrograde Intubation Set
|
Cook Incorporated |
DEN170055 |
|
12/12/2018 |
Alethia CMV DNA Amplification Assay, Ale
|
Meridian Bioscience, Inc. |
DEN180040 |
|
11/30/2018 |
QMS Plazomicin Immunoassay
|
Microgenics Corporation |
DEN180030 |
|
11/19/2018 |
Innovo
|
Bio-Medical Research Ltd. |
DEN170049 |
|
11/06/2018 |