Approval for a modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (atellica direct load) for the atellica im analyzer (immunoassay module)
| Device | Atellica IM Hepatitis B core IgM (aHBcM) Assay |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2020-03-09 |
| Decision Date | 2020-04-03 |
| PMA | P030040 |
| Supplement | S017 |
| 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 | SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030040 | | Original Filing |
| S021 |
2022-03-22 |
30-day Notice |
| S020 |
2021-04-01 |
30-day Notice |
| S019 |
2020-12-22 |
Real-time Process |
| S018 |
2020-07-31 |
30-day Notice |
| S017 |
2020-03-09 |
30-day Notice |
| S016 |
2020-02-21 |
30-day Notice |
| S015 |
2019-02-01 |
30-day Notice |
| S014 |
2018-08-15 |
Normal 180 Day Track No User Fee |
| S013 |
2018-07-19 |
Real-time Process |
| S012 |
2017-06-16 |
Normal 180 Day Track |
| S011 |
2016-07-05 |
Normal 180 Day Track |
| S010 |
2015-06-11 |
30-day Notice |
| S009 |
2015-05-14 |
Normal 180 Day Track |
| S008 |
2012-03-26 |
Normal 180 Day Track No User Fee |
| S007 |
2010-02-18 |
30-day Notice |
| S006 |
2009-05-18 |
Normal 180 Day Track |
| S005 |
2009-03-31 |
Normal 180 Day Track |
| S004 |
2009-03-09 |
Normal 180 Day Track No User Fee |
| S003 |
2009-02-04 |
30-day Notice |
| S002 |
2008-08-11 |
Normal 180 Day Track |
| S001 | | |
NIH GUDID Devices