# K945433: Etest/Ceftriaxone/Haemophilus/Pneumococcus

- Pathway: 510(k) (Traditional)
- Applicant: Ab Biodisk
- Decided: Mar 17, 1995 after 144 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- 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
- Jan 1, 2017 · Class II · Z-2126-2017: Potential performance issue on strain categorization.

Source page: https://510kreport.com/device/K945433
Methodology: https://510kreport.com/methodology