# K070691: BBL Chromagar 0157

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Nov 20, 2007 after 252 days
- Product code: JSI (Culture Media, Selective And Differential)
- Device class: 1
- Regulation: 21 CFR 866.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871855 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871855: Sorbitol Macconkey (Smac) Agar, Dri & Pre-Form, Gibco Laboratories Life Technologies, Inc. (1987) Summary page 1.

## Indications for use
BD BBL Tm CHROMagar TM 0157 is a selective medium for the isolation, differentiation and presumptive identification of Escherichiacoli 0157:H7 from clinical human stool specimens.

Source page: https://510kreport.com/device/K070691
Methodology: https://510kreport.com/methodology