|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
ETI-EBK PLUS Assay
|
DIASORIN, INC. |
P990043 S028 |
06/28/2018 |
ETI-EBK PLUS Assay
|
DIASORIN, INC. |
P990043 S027 |
04/24/2018 |
ETI-EBK PLUS Assay
|
DIASORIN, INC. |
P990043 S025 |
03/14/2018 |
ETI-AB-AUK PLUS Assay
|
DIASORIN, INC. |
P990042 S024 |
06/28/2018 |
ETI-AB-AUK PLUS Assay
|
DIASORIN, INC. |
P990042 S023 |
04/24/2018 |
ETI-AB-AUK PLUS Assay
|
DIASORIN, INC. |
P990042 S021 |
03/14/2018 |
ETI-MAK-2 PLUS, HBsAg Confirmatory Test Assays
|
DIASORIN, INC. |
P990038 S028 |
06/28/2018 |
ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays
|
DIASORIN, INC. |
P990038 S027 |
04/24/2018 |
ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays
|
DIASORIN, INC. |
P990038 S025 |
03/14/2018 |
Elecsys HBsAg Immunoassay
|
ROCHE DIAGNOSTICS CORP. |
P990012 S032 |
06/13/2018 |
|