|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
Alinity m HR HPV
|
Abbott Molecular, Inc |
P230003 |
11/01/2023 |
BD Onclarity HPV
|
BECTON, DICKINSON AND COMPANY |
P160037 S016 |
11/15/2023 |
BD Onclarity HPV Assay
|
BECTON, DICKINSON AND COMPANY |
P160037 S014 |
04/12/2023 |
BD Onclarity HPV Assay
|
BECTON, DICKINSON AND COMPANY |
P160037 S018 |
11/20/2023 |
BD Onclarity HPV Assay
|
BECTON, DICKINSON AND COMPANY |
P160037 S008 |
02/09/2023 |
BD Onclarity™ HPV Assay
|
BECTON, DICKINSON AND COMPANY |
P160037 S015 |
02/27/2023 |
BD Onclarity™ HPV Assay
|
BECTON, DICKINSON AND COMPANY |
P160037 S012 |
02/15/2023 |
cobas HPV
|
Roche Molecular Systems, Inc. |
P190028 S013 |
12/14/2023 |
cobas HPV Test, 240 Tests, cobas HPV Test, 960 Tes...
|
Roche Molecular Systems, Inc. |
P100020 S056 |
08/17/2023 |
cobas® 4800 HPV Test
|
Roche Molecular Systems, Inc. |
P100020 S057 |
08/23/2023 |