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 Anti-HBe2 Assay |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Siemens Healthcare Diagnostics, Inc.511 Benedict Avenuetarrytown, NY 10591-5097 PMA NumberP200017 Supplement NumberS002 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-22 |
| Decision Date | 2022-03-29 |
| PMA | P200017 |
| Supplement | S002 |
| 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, Inc. 511 Benedict Avenue tarrytown, NY 10591-5097 PMA NumberP200017 Supplement NumberS002 Date Received03/22/2022 Decision Date03/29/2022 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 to Manufacture An Instrument Component At Another Location |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200017 | Original Filing | |
| S002 | 2022-03-22 | 30-day Notice |
| S001 | 2021-08-10 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 00842768022678 | P200017 | 001 |