PMA supplement
P010054 S034: Elecsys Anti-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck
FDA PMA supplement · Normal 180 Day Track No User Fee · Roche Diagnostics Corp.
Key facts
| Original PMA | P010054 |
|---|---|
| Supplement number | S034 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Elecsys Anti-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Roche Diagnostics Corp. |
| Product code | LOM |
| Received date | Feb 1, 2018 |
| Decision date | May 17, 2018 |
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: