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 and 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 NumberS017 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOK Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-15 |
| Decision Date | 2022-10-14 |
| PMA | P010007 |
| Supplement | S017 |
| 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 NumberS017 Date Received09/15/2022 Decision Date10/14/2022 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 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 |
|---|---|---|
| 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 |