Change to an environmentally controlled room used for dispensing vitros reagents.
Device | VITROS ANTI-HBC IGM ASSAY |
Classification Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
Applicant | Ortho-Clinical Diagnostics, Inc. |
Date Received | 2015-08-10 |
Decision Date | 2015-09-08 |
PMA | P030026 |
Supplement | S030 |
Product Code | LOM |
Advisory Committee | Microbiology |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr. rochester, NY 14626-5101 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P030026 | | Original Filing |
S037 |
2022-09-30 |
Real-time Process |
S036 |
2019-05-21 |
30-day Notice |
S035 |
2018-10-16 |
Normal 180 Day Track No User Fee |
S034 |
2018-02-21 |
Normal 180 Day Track No User Fee |
S033 |
2018-01-16 |
30-day Notice |
S032 |
2018-01-09 |
Normal 180 Day Track No User Fee |
S031 |
2015-10-05 |
30-day Notice |
S030 |
2015-08-10 |
30-day Notice |
S029 |
2015-01-16 |
30-day Notice |
S028 |
2013-09-20 |
30-day Notice |
S027 |
2012-11-29 |
30-day Notice |
S026 |
2012-10-17 |
30-day Notice |
S025 |
2012-01-30 |
30-day Notice |
S024 |
2011-10-05 |
Real-time Process |
S023 |
2011-05-19 |
30-day Notice |
S022 |
2011-05-16 |
135 Review Track For 30-day Notice |
S021 |
2010-12-08 |
30-day Notice |
S020 |
2010-10-18 |
30-day Notice |
S019 |
2009-12-01 |
Normal 180 Day Track No User Fee |
S018 |
2009-05-22 |
30-day Notice |
S017 |
2009-03-06 |
30-day Notice |
S016 |
2009-02-20 |
Normal 180 Day Track |
S015 |
2008-11-13 |
Normal 180 Day Track No User Fee |
S014 |
2008-02-27 |
30-day Notice |
S013 |
2007-03-08 |
30-day Notice |
S012 |
2007-02-07 |
Special (immediate Track) |
S011 |
2006-08-21 |
30-day Notice |
S010 |
2006-05-17 |
30-day Notice |
S009 |
2005-11-14 |
30-day Notice |
S008 |
2005-09-30 |
Special (immediate Track) |
S007 |
2005-06-27 |
30-day Notice |
S006 |
2005-06-03 |
30-day Notice |
S005 |
2005-04-07 |
30-day Notice |
S004 |
2004-12-21 |
30-day Notice |
S003 |
2004-12-15 |
30-day Notice |
S002 |
2004-10-26 |
30-day Notice |
S001 |
2004-05-24 |
30-day Notice |
NIH GUDID Devices