# K831469: Legionella Cye Agar Base & Bcye Suppl

- Pathway: 510(k) (Traditional)
- Applicant: Oxoid U.S.A., Inc.
- Decided: Jun 8, 1983 after 33 days
- Product code: JSK (Supplement, Culture Media)
- Device class: 1
- Regulation: 21 CFR 866.2450
- Recalls of this device: 4 (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
- Feb 5, 2015 · Class II · Z-1232-2015: Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.
- Nov 13, 2014 · Class II · Z-0578-2015: Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.
- Oct 17, 2014 · Class II · Z-0200-2015: Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.
- Jan 24, 2014 · Class II · Z-1112-2014: The product may contain high levels of microbial contamination

Source page: https://510kreport.com/device/K831469
Methodology: https://510kreport.com/methodology