PMA
P980046: HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS
FDA PMA · Immunoassay for the detection of antibody to Hepatitis C Virus intended for over the counter use · Pwn Health Chicago, LLC
Key facts
| PMA number | P980046 |
|---|---|
| Trade name | HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS |
| Generic name | Immunoassay for the detection of antibody to Hepatitis C Virus intended for over the counter use |
| Applicant | Pwn Health Chicago, LLC |
| Product code | QRO |
| Approval date | Apr 28, 1999 |
| Docket number | 99M-2143 |
| Notice date | Jul 13, 1999 |
| FEI number | 3000206414 |
At a glance
- 1–9 Supplements
- Dec 9, 2015 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- No Withdrawn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: