PMA
P970027: ABBOTT AXSYM ANTIBODY TO HCV
FDA PMA · Assay, enzyme linked immunosorbent, hepatitis c virus · Abbott Laboratories
Key facts
| PMA number | P970027 |
|---|---|
| Trade name | ABBOTT AXSYM ANTIBODY TO HCV |
| Generic name | Assay, enzyme linked immunosorbent, hepatitis c virus |
| Applicant | Abbott Laboratories |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MZO |
| Approval date | Feb 5, 2004 |
| Docket number | 04M-0207 |
| Notice date | May 5, 2004 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 10–99 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- Yes Withdrawn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: