# K864803: GC-Lect (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Feb 3, 1987 after 56 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jun 21, 2018 · Class II · Z-2869-2018: A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an inhibitory agent of Neisseria organisms. This product is a selective plated medium to provide enhanced g

Source page: https://510kreport.com/device/K864803
Methodology: https://510kreport.com/methodology