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 | IMMULITE 2000 Anti-HBc IgM |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010053 Supplement NumberS014 Date Received02/28/2022 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 | 2022-02-28 |
| Decision Date | 2022-03-29 |
| PMA | P010053 |
| Supplement | S014 |
| 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 Products, LTD glyn Rhonwy llanberis, Caernarfon LL55 PMA NumberP010053 Supplement NumberS014 Date Received02/28/2022 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 a Manufacturing Process Change For A Critical Raw Material |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010053 | Original Filing | |
| S016 | 2022-09-15 | 30-day Notice |
| S015 | ||
| S014 | 2022-02-28 | 30-day Notice |
| S013 | 2020-12-22 | Real-time Process |
| S012 | 2020-08-12 | 30-day Notice |
| S011 | 2019-11-25 | 30-day Notice |
| S010 | 2011-12-19 | 135 Review Track For 30-day Notice |
| S009 | 2011-08-16 | 30-day Notice |
| S008 | 2011-08-08 | 30-day Notice |
| S007 | 2011-02-18 | Real-time Process |
| S006 | 2009-11-02 | Normal 180 Day Track No User Fee |
| S005 | ||
| S004 | 2008-11-10 | Normal 180 Day Track No User Fee |
| S003 | 2005-08-17 | Special (immediate Track) |
| S002 | ||
| S001 | 2002-11-20 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 00630414977737 | P010053 | 001 |
| 00630414977720 | P010053 | 001 |
| 00630414960975 | P010053 | 001 |