# K093807: Hardydisk Ast Telavancin,30UG

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Jan 8, 2010 after 28 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™ Telavancin 30 µg for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to telavancin. The concentration of Telavancin 30 µg has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections: Methicillin-resistant staphylococci, streptococci, and vancomycin-susceptible enterococci.

Source page: https://510kreport.com/device/K093807
Methodology: https://510kreport.com/methodology