# K960996: M. Cat Butyrate Disk

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Apr 18, 1996 after 37 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Dec 1, 2021 · Class II · Z-0554-2022: Product stored incorrectly in temperature controlled setting instead of refrigeration.

Source page: https://510kreport.com/device/K960996
Methodology: https://510kreport.com/methodology