Cleared Traditional

HardyDisk AST Rezafungin 5?g (RZF5)

K230827 · Hardy Diagnostics · Microbiology
Jun 2023
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K230827 is an FDA 510(k) clearance for the HardyDisk AST Rezafungin 5?g (RZF5), a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Hardy Diagnostics (Santa Monica, US). The FDA issued a Cleared decision on June 1, 2023, 66 days after receiving the submission on March 27, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K230827 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2023
Decision Date June 01, 2023
Days to Decision 66 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JTN — Susceptibility Test Discs, Antimicrobial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1620

Similar Devices — JTN Susceptibility Test Discs, Antimicrobial

All 326
Thermo Scientific Oxoid Gepotidacin Disc (10 ?g) GEP10
K251337 · Thermo Fisher Scientific (Oxoid Ltd.) · Dec 2025
HardyDisk AST Cefiderocol 30?g (FDC30)
K253105 · Hardy Diagnostics · Nov 2025
Sulopenem SPM 2 ?g
K251879 · Liofilchem · Aug 2025
HardyDisk AST Gepotidacin 10?g (GEP10)
K250956 · Hardy Diagnostics · Jun 2025
Ceftobiprole BPR 5 ?g Disc
K250885 · Liofilchem, Inc. · Jun 2025
Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 ?g) AZA50
K250789 · Thermo Fisher Scientific (Oxoid Ltd.) · Jun 2025