HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)— 510(k) K191931

Name: FDA 510(k) clearance K191931
Creator: U.S. Food and Drug Administration
Published: 2019-07-31

Substantially Equivalent

Hardy Diagnostics

FDA 510(k) clearance K191931 for HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25), Substantially Equivalent on 2019-07-31. Applicant: Hardy Diagnostics. Device class: 2.

Clearance details

Applicant: Hardy Diagnostics
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 2019-07-19
Decision date: 2019-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Maria, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTN

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K262113 — HardyDisk AST Tebipenem 10µg (TBP10)2026-08-20
K261781 — Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ602026-07-24
K261853 — Gepotidacin GEP 10 µg2026-07-23
K260842 — HardyDisk AST Gepotidacin 10µg (GEP10)2026-05-11
K251337 — Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP102025-12-05

More clearances from Hardy Diagnostics

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K253105 — HardyDisk AST Cefiderocol 30µg (FDC30)2025-11-20
K250956 — HardyDisk AST Gepotidacin 10µg (GEP10)2025-06-26
K250454 — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)2025-05-15
K233534 — Viral Transport Medium2024-08-02
K241060 — HardyDisk AST Cefiderocol 30µg (FDC30)2024-07-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.