# K954986: GC Base W/ 1% Gchi

- Pathway: 510(k) (Traditional)
- Applicant: Remel, L.P.
- Decided: Feb 16, 1996 after 108 days
- Product code: JTY (Culture Media, For Isolation Of Pathogenic Neisseria)
- Device class: 2
- Regulation: 21 CFR 866.2410
- Recalls of this device: 1 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jun 3, 2026 · Class II · Z-2623-2026: Reduced or no recovery of some strains of Neisseria gonorrhoeae.

Source page: https://510kreport.com/device/K954986
Methodology: https://510kreport.com/methodology