# K994135: Hardydisk Erythromycin, 15MCG

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Feb 16, 2000 after 71 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 Diska are used for semi-quantitative J]n vitra susceptibility testing by the agar diffusion test proccdure (Kirby-Bauer) of rapidly growin g and certain fastidious bacteriul pathogens. Standardized methods for agar diffusion testing have been described for Eutciobacteriaccac, Staphylococcus spp., Pseudomanas spp., Acinerobacter spp., Listérta monocytogenes, Lnterococcus spp., other streptococci and, by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptacoccus pneumdhiae. Hd.l’dyDlSk"" Crythromyecin is indicated for in vitro activity against Staphvlococcu.s spp., and Stregrtococcus spp. including . prneumoniae.

Source page: https://510kreport.com/device/K994135
Methodology: https://510kreport.com/methodology