Approval for the placement of these assays on the atellica solution.
| Device | Atellica IM Hepatitis B e Antigen (HBeAg) |
| Classification Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2018-07-19 |
| Decision Date | 2018-09-11 |
| PMA | P090024 |
| Supplement | S005 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue tarrytown, NY 10591 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P090024 | | Original Filing |
| S011 |
2022-03-22 |
30-day Notice |
| S010 |
2021-04-01 |
30-day Notice |
| S009 |
2020-07-31 |
30-day Notice |
| S008 |
2020-03-09 |
30-day Notice |
| S007 |
2020-02-21 |
30-day Notice |
| S006 |
2019-02-01 |
30-day Notice |
| S005 |
2018-07-19 |
Real-time Process |
| S004 |
2017-12-22 |
Normal 180 Day Track |
| S003 |
2017-03-27 |
30-day Notice |
| S002 |
2015-06-11 |
30-day Notice |
| S001 |
2015-05-05 |
Normal 180 Day Track |
NIH GUDID Devices