# K926018: Crystal Enteric/Nonfermenter ID System

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Microbiology Systems
- Decided: Mar 11, 1993 after 101 days
- Product code: JSS (Kit, Identification, Enterobacteriaceae)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: 2 (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
- May 21, 2014 · Class III · Z-2041-2014: A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates. A portion of these kits contain Crystal I
- Dec 13, 2012 · Class II · Z-0699-2013: In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification.

Source page: https://510kreport.com/device/K926018
Methodology: https://510kreport.com/methodology