PMA supplement
P010050 S021: IMMULITE® 2000 HBsAg and IMMULITE® 2000 HBsAg Confirmatory Kit’
FDA PMA supplement · 30-Day Notice · Siemens Healthcare Diagnostics Products, Ltd.
Key facts
| Original PMA | P010050 |
|---|---|
| Supplement number | S021 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | IMMULITE® 2000 HBsAg and IMMULITE® 2000 HBsAg Confirmatory Kit’ |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Siemens Healthcare Diagnostics Products, Ltd. |
| Product code | LOM |
| Received date | Sep 15, 2022 |
| Decision date | Oct 14, 2022 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: