PMA supplement
BP870003 S002: Ortho HBc Antibody ELISA Test System
FDA PMA supplement · Normal 180 Day Track · Ortho-Clinical Diagnostics, In
Key facts
| Original PMA | BP870003 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track |
| Trade name | Ortho HBc Antibody ELISA Test System |
| Generic name | Identification system for hepatitis b antigen |
| Applicant | Ortho-Clinical Diagnostics, In |
| Product code | KSJ |
| Received date | Feb 17, 1989 |
| Decision date | Jan 10, 1991 |
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: