PMA
P140021: ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
FDA PMA · Assay, enzyme linked immunosorbent, hepatitis c virus · Roche Diagnostics Operations, Inc.
Key facts
| PMA number | P140021 |
|---|---|
| Trade name | ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV |
| Generic name | Assay, enzyme linked immunosorbent, hepatitis c virus |
| Applicant | Roche Diagnostics Operations, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | MZO |
| Approval date | Jun 11, 2015 |
| Docket number | 15M-2217 |
| Notice date | Jul 10, 2015 |
| Establishment registration | 1823260 |
| FEI number | 1823260 |
At a glance
- 10–99 Supplements
- Apr 24, 2019 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: