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 Alpha Fetoprotein (AFP) Assay |
| Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC.333 Coney Streeteast Walpole, MA 02032 PMA NumberP930036 Supplement NumberS019 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOK Advisory Committee Immunology 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 | P930036 |
| Supplement | S019 |
| Product Code | LOK |
| Advisory Committee | Immunology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS INC. 333 Coney Street east Walpole, MA 02032 PMA NumberP930036 Supplement NumberS019 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOK Advisory Committee Immunology 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 |
|---|---|---|
| P930036 | Original Filing | |
| S020 | 2022-09-01 | 30-day Notice |
| S019 | 2022-03-22 | 30-day Notice |
| S018 | 2021-08-11 | Real-time Process |
| S017 | 2021-07-26 | 30-day Notice |
| S016 | 2021-04-01 | 30-day Notice |
| S015 | 2020-07-31 | 30-day Notice |
| S014 | 2020-03-09 | 30-day Notice |
| S013 | 2020-02-21 | 30-day Notice |
| S012 | ||
| S011 | 2019-02-01 | 30-day Notice |
| S010 | 2018-12-06 | Normal 180 Day Track |
| S009 | 2018-07-27 | Real-time Process |
| S008 | 2017-09-01 | Normal 180 Day Track |
| S007 | 2016-10-20 | 135 Review Track For 30-day Notice |
| S006 | 2015-07-17 | Normal 180 Day Track |
| S005 | 2012-03-26 | Normal 180 Day Track No User Fee |
| S004 | 2012-02-15 | 135 Review Track For 30-day Notice |
| S003 | 2005-07-22 | Real-time Process |
| S002 | 2002-01-16 | Real-time Process |
| S001 | 1998-05-01 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 00630414597720 | P930036 | 001 |
| 00630414124797 | P930036 | 001 |
| 00630414124933 | P930036 | 001 |
| 00630414124940 | P930036 | 001 |
| 00630414126319 | P930036 | 001 |
| 00630414177328 | P930036 | 001 |
| 00630414177335 | P930036 | 001 |
| 00630414022963 | P930036 | 001 |
| 00630414238791 | P930036 | 008 |
| 00630414238807 | P930036 | 008 |