# P770001: Fluorescent Gonorrhea Test-Heated (FGT-H)

- Pathway: PMA
- Applicant: Fisher Scientific Co., LLC
- Decided: Jul 18, 1979 after 789 days
- Product code: LGB (Gonococcal Antibody Tests)
- Device class: 3
- Regulation: 21 CFR 866.3290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P770001
Methodology: https://510kreport.com/methodology