|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
Aptima HCV Quant Dx Assay
|
HOLOGIC, INC. |
P160023 S008 |
12/28/2018 |
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and CO...
|
Roche Molecular Systems, Inc. |
P060030 S071 |
12/13/2018 |
cobas HCV
|
Roche Molecular Systems, Inc. |
P150015 S022 |
12/13/2018 |
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and CO...
|
Roche Molecular Systems, Inc. |
P060030 S070 |
12/07/2018 |
cobas HCV
|
Roche Molecular Systems, Inc. |
P150015 S021 |
12/07/2018 |
Aptima HCV RNA Qualitative Assay
|
GEN-PROBE |
P020011 S011 |
10/31/2018 |
Aptima HCV Quant DX Assay
|
HOLOGIC, INC. |
P160023 S007 |
10/31/2018 |
Aptima HCV Quant Dx Assay
|
HOLOGIC, INC. |
P160023 S004 |
10/16/2018 |
Aptima HCV Quant Dx Assay
|
HOLOGIC, INC. |
P160023 S006 |
09/26/2018 |
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and CO...
|
Roche Molecular Systems, Inc. |
P060030 S069 |
09/19/2018 |