PMA
P840070: HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST
FDA PMA · Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) · Organon Teknika Corp.
Key facts
| PMA number | P840070 |
|---|---|
| Trade name | HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Organon Teknika Corp. |
| Owner/operator | Organon LLC |
| Product code | LOM |
| Approval date | May 14, 1986 |
| Docket number | 86M-0238 |
| Notice date | Jul 1, 1986 |
| Establishment registration | 3017425145 |
| FEI number | 2211109 |
At a glance
- 1–9 Supplements
- Mar 21, 1990 Latest supplement decision
- No Withdrawn
- No 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: