PMA
P770001: FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)
FDA PMA · GONOCOCCAL ANTIBODY TESTS · Fisher Scientific Co., LLC
Key facts
| PMA number | P770001 |
|---|---|
| Trade name | FLUORESCENT GONORRHEA TEST-HEATED (FGT-H) |
| Generic name | GONOCOCCAL ANTIBODY TESTS |
| Applicant | Fisher Scientific Co., LLC |
| Owner/operator | Instrumentation Laboratory Co. |
| Product code | LGB |
| Approval date | Jul 18, 1979 |
| Notice date | Jun 13, 1980 |
| Establishment registration | 2431530 |
| FEI number | 2431530 |
At a glance
- None Supplements
- Jul 18, 1979 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- No Withdrawn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: