|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
Elecsys HBsAg II
|
ROCHE DIAGNOSTICS, INC. |
P160019 S016 |
02/08/2024 |
Elecsys HBsAg II, Elecsys HBsAg II Auto Confirm
|
ROCHE DIAGNOSTICS, INC. |
P160019 S015 |
10/31/2023 |
Elecsys HBsAg II, PreciControl HBsAg II, Elecsys H...
|
ROCHE DIAGNOSTICS, INC. |
P160019 S014 |
04/24/2023 |
Elecsys HBsAg II
|
ROCHE DIAGNOSTICS, INC. |
P160019 S013 |
12/16/2021 |
Elecsys HBsAg Confirmatory Test
|
ROCHE DIAGNOSTICS, INC. |
P160019 S012 |
12/09/2021 |
Elecsys HBsAg II Auto Confirm
|
ROCHE DIAGNOSTICS, INC. |
P160019 S011 |
10/19/2020 |
Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test,...
|
ROCHE DIAGNOSTICS, INC. |
P160019 S010 |
02/27/2020 |
Elecsys HBsAg II
|
ROCHE DIAGNOSTICS, INC. |
P160019 S009 |
04/24/2019 |
Elecsys HBsAg II (100/200 tests)
|
ROCHE DIAGNOSTICS, INC. |
P160019 S008 |
11/06/2018 |
Elecsys HBsAg II
|
ROCHE DIAGNOSTICS, INC. |
P160019 S007 |
06/13/2018 |
|