This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Atellica® IM Anti-Hepatitis B core Total (HBcT) Assay |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP040004 Supplement NumberS021 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-22 |
| Decision Date | 2022-03-29 |
| PMA | P040004 |
| Supplement | S021 |
| 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 PMA NumberP040004 Supplement NumberS021 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Manufacture An Instrument Component At Another Location |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040004 | 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 | 2018-07-19 | Real-time Process |
| S013 | 2017-07-17 | Normal 180 Day Track |
| S012 | 2015-07-13 | Normal 180 Day Track |
| S011 | 2015-06-11 | 30-day Notice |
| S010 | 2014-09-09 | Normal 180 Day Track |
| S009 | 2012-03-26 | Normal 180 Day Track No User Fee |
| S008 | 2012-01-09 | 30-day Notice |
| S007 | 2010-01-08 | 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 | 2008-08-26 | Normal 180 Day Track |
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| 00630414498089 | P040004 | 000 |
| 00630414599212 | P040004 | 002 |
| 00630414599205 | P040004 | 002 |
| 00630414498096 | P040004 | 002 |
| 00630414301303 | P040004 | 002 |