Identifiers
- 510(k) Number
- K002369 FDA 510(k)
- FDA Product Code
- JTN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.1620 FDA 510(k)
- Regulation Number
- 866.1620 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HardyDisk Gentamicin, 120MCG is an antimicrobial susceptibility test disc used for disk diffusion testing, also known as Kirby-Bauer testing. It is designed to determine bacterial susceptibility to gentamicin, an aminoglycoside antibiotic, by measuring the zone of inhibition around the disc when placed on an inoculated agar plate.
These discs are supplied as part of a cartridge system compatible with BBL single or multiple disk dispensers, each containing 50 spring-loaded discs for reliable dispensing. The device is classified as a Class II medical device under FDA regulation 866.1620 and is intended for use in microbiology laboratories. It is not sterile and is intended for single-use only, with no specific MRI safety considerations noted.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HardyDisk™ AST Gentamicin, GM10 - hardydiagnostics.com, HARDYDISK GENTAMICIN, 120MCG (K002369) — FDA 510(k) | Innolitics, HARDYDISK GENTAMICIN, 120MCG (K002369) — FDA 510(k) | Innolitics, HardyDisks™ for Antibiotic Resistance/Antibiotic ... - Hardy Diagnostics, K994091 FDA 510(k) - HARDYDISK GENTAMICIN | Hardy Diagnostics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002369 | Class II | Active |
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Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA 510(k) K002369 24 fields · synced Sep 19, 2026