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/IMMULITE 1000 AFP, IMMULITE 2000 AFP |
| Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC.511 Benedict Ave.tarrytown, NY 10591 PMA NumberP010007 Supplement NumberS015 Date Received02/28/2022 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 | 2022-02-28 |
| Decision Date | 2022-03-29 |
| PMA | P010007 |
| Supplement | S015 |
| 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. 511 Benedict Ave. tarrytown, NY 10591 PMA NumberP010007 Supplement NumberS015 Date Received02/28/2022 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 implementation Of A Change To The Physical State Of A Raw Material |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010007 | Original Filing | |
| S017 | 2022-09-15 | 30-day Notice |
| S016 | ||
| S015 | 2022-02-28 | 30-day Notice |
| S014 | 2021-04-14 | 30-day Notice |
| S013 | 2020-08-12 | 30-day Notice |
| S012 | 2020-07-23 | 30-day Notice |
| S011 | 2019-11-25 | 30-day Notice |
| S010 | 2018-09-28 | Real-time Process |
| S009 | 2012-05-30 | 135 Review Track For 30-day Notice |
| S008 | 2011-12-19 | 135 Review Track For 30-day Notice |
| S007 | 2011-08-16 | 30-day Notice |
| S006 | 2011-08-08 | 30-day Notice |
| S005 | 2011-02-18 | Real-time Process |
| S004 | 2009-11-02 | Normal 180 Day Track No User Fee |
| S003 | ||
| S002 | 2003-12-12 | Real-time Process |
| S001 | 2003-01-21 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 00630414963594 | P010007 | 001 |
| 00630414961040 | P010007 | 001 |
| 00630414961033 | P010007 | 001 |
| 00630414953519 | P010007 | 001 |