# K994132: Hardydisk Imipenem, 10MCG

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Jan 18, 2000 after 42 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™ Imipenem Antimicrobial Sensitivity Disks arc used for scmi-quantitative in vitro susceptibility testingpy the agar diffusion test procedure (Kirby-Baucr) of rapidly growing and certain tastidious badterial pathogens. Standardized methods for agar diffusion testing have been described tor Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Enterncocens spp., other streptococei and, by modified procedures, Haemophilus influcnzae, and Streptococcus pneuniomine.

Source page: https://510kreport.com/device/K994132
Methodology: https://510kreport.com/methodology