# K973457: Chromalex E. Coli 0157 Latex Test System, Prod. NO. 800

- Pathway: 510(k) (Traditional)
- Applicant: Shared Systems, Inc.
- Decided: Jan 2, 1998 after 112 days
- Product code: GMZ (Antigens, All Types, Escherichia Coli)
- Device class: 1
- Regulation: 21 CFR 866.3255
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The E. coli 0157 Latex Agglutination Test is a rapid test for E. coli serogroup 0157 detection in all primary cultures suspected to be E. coli spp.

Source page: https://510kreport.com/device/K973457
Methodology: https://510kreport.com/methodology