# K896398: Difco Oxidase Dryslide

- Pathway: 510(k) (Traditional)
- Applicant: Difco Laboratories, Inc.
- Decided: Dec 18, 1989 after 42 days
- Product code: JTO (Discs, Strips And Reagents, Microorganism Differentiation)
- Device class: 1
- Regulation: 21 CFR 866.2660
- 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
- Apr 12, 2013 · Class II · Z-1423-2013: In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.

Source page: https://510kreport.com/device/K896398
Methodology: https://510kreport.com/methodology