|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
Adaptive Biotechnologies clonoSEQ Assay
|
Adaptive Biotechnologies Corporation |
DEN170080 |
|
09/28/2018 |
Bose Hearing Aid
|
Bose Corporation |
DEN180026 |
|
10/05/2018 |
picoAMH ELISA
|
Ansh Labs LLC |
DEN180004 |
|
10/24/2018 |
23andMe Personal Genome Service (PGS) Ph
|
23andMe, Inc. |
DEN180028 |
|
10/31/2018 |
Parathyroid Detection (Model PTeye) Syst
|
AiBiomed, Corp. |
DEN170056 |
|
11/02/2018 |
Fluobeam 800 Clinic Imaging Device used
|
Fluoptics |
DEN170092 |
|
11/02/2018 |
Innovo
|
Bio-Medical Research Ltd. |
DEN170049 |
|
11/06/2018 |
QMS Plazomicin Immunoassay
|
Microgenics Corporation |
DEN180030 |
|
11/19/2018 |
Alethia CMV DNA Amplification Assay, Ale
|
Meridian Bioscience, Inc. |
DEN180040 |
|
11/30/2018 |
Retrograde Intubation Set
|
Cook Incorporated |
DEN170055 |
|
12/12/2018 |