# K994134: Hardydisk Oxacillin, 1MCG

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Feb 17, 2000 after 72 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
HardyDisk™ Antimicrobial Sensitivity Disks are used for seml-quantnatxve in vitro t'uscept.lblhty testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria mouowmgpgw , Enterocoecus spp., other streptocacei and, by moditied pracedures, Haemophilus influenzne, Neisseria gonorrhoene and Streptococcus preumoniae. HardyDisk™ Oxacillin is indicated for in vitro activity against Staphylococcus spp. and Streprococcus pneumioniae.

Source page: https://510kreport.com/device/K994134
Methodology: https://510kreport.com/methodology