PMA
P850062: ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA)
FDA PMA · HEPATITIS DELTA SEROLOGICAL REAGENTS · Abbott Laboratories
Key facts
| PMA number | P850062 |
|---|---|
| Trade name | ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA) |
| Generic name | HEPATITIS DELTA SEROLOGICAL REAGENTS |
| Applicant | Abbott Laboratories |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LQI |
| Approval date | Jul 1, 1986 |
| Docket number | 86M-0308 |
| Notice date | Aug 7, 1986 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 1–9 Supplements
- Sep 5, 2002 Latest supplement decision
- Yes Withdrawn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: