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 NumberS016 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-15 |
| Decision Date | 2022-10-14 |
| PMA | P010053 |
| Supplement | S016 |
| 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 NumberS016 Date Received09/15/2022 Decision Date10/14/2022 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 Change In Material Composition Of The Glass Bulb Used In PMT (Photo Multiplier Tube) Assembly On The IMMULITE Family Of Instruments. |
| 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 |