|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
ETI-MAK-2 PLUS and HBsAg Confirmatory Test assay
|
DIASORIN, INC. |
P990038 S032 |
12/21/2021 |
ETI-AB-AUK PLUS assay
|
DIASORIN, INC. |
P990042 S028 |
12/21/2021 |
ETI-EBK PLUS assay
|
DIASORIN, INC. |
P990043 S032 |
12/21/2021 |
ETI-MAK-2 PLUS and HBsAg Confirmatory Test assays
|
DIASORIN, INC. |
P990038 S031 |
08/13/2020 |
ETI-AB-AUK PLUS assay
|
DIASORIN, INC. |
P990042 S027 |
08/13/2020 |
ETI-EBK PLUS assay
|
DIASORIN, INC. |
P990043 S031 |
08/13/2020 |
ETI MAK-2 PLUS Assay and HBsAg Confirmatory Test
|
DIASORIN, INC. |
P990038 S030 |
09/27/2019 |
ETI-AB-AUK PLUS assay
|
DIASORIN, INC. |
P990042 S026 |
09/27/2019 |
ETI-EBK PLUS Aassay
|
DIASORIN, INC. |
P990043 S030 |
09/27/2019 |
ETI-MAK-2 Plus Assay
|
DIASORIN, INC. |
P990038 S029 |
07/18/2019 |
|