# K993993: Hardydisk Amikacin 30MCG

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Dec 27, 1999 after 33 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™ Antlmlcmhml Sensitivity Disks are used for .,em.l-qunnutauve in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growmg and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been Jescribed for EBnterobacteriaceae, Staphylococcus spp., Psexdomonas spp., Acinetobacter spp., Listerla monocyrogenes, Enterococcus spp., other streptocei and, by modified procedurcs, Huernophilus influenzae, Nelsseria gonnrrhoeae and Streptococcus pneumoniac. UardyDisk™ Atmikactn is indicated for gram negahve Enterobacteriaciae including Escherichia coli, Proteus spp., Prvvidencia spp.. Klebsiellu-Enterohacier-Nerratia spp., Citrobacter Spp-Acinetobacter spp, ad Pseudomonas aeruginosa. HardyDisk™ Amikacin is also active in vitro against Staphylococcis spp.

Source page: https://510kreport.com/device/K993993
Methodology: https://510kreport.com/methodology