PMA supplement
BP860031 S004: CORE-IGMK
FDA PMA supplement · Normal 180 Day Track · DiaSorin, Inc.
Key facts
| Original PMA | BP860031 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track |
| Trade name | CORE-IGMK |
| Generic name | Identification system for hepatitis b antigen |
| Applicant | DiaSorin, Inc. |
| Product code | KSJ |
| Received date | Jun 8, 2001 |
| Decision date | Aug 13, 2002 |
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: