PMA
P060009: AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS
FDA PMA · Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) · Abbott Laboratories, Inc.
Key facts
| PMA number | P060009 |
|---|---|
| Trade name | AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Abbott Laboratories, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LOM |
| Approval date | Aug 25, 2006 |
| Docket number | 07M-0160 |
| Notice date | Apr 30, 2007 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 1–9 Supplements
- Dec 5, 2012 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: