# K152846: HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Nov 24, 2015 after 56 days
- Product code: JTN (Susceptibility Test Discs, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1620
- Recalls of this device: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Use of HardyDisk AST Ceftolozane/Tazobactam, (30/10pg) - C/T40, for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Ceftolozane/Tazobactam. The concentration of Ceftolozane/Tazobactam, (30/10pg) - C/T40, has been shown to be active against most isolates of Pseudomonas aeruginosa both in vitro and in clinical infections.

Source page: https://510kreport.com/device/K152846
Methodology: https://510kreport.com/methodology