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FDA 510(k)

HardyDisk AST Rezafungin 5µg (RZF5)

K-Number: K230827 · 2023-06-01

ApplicantHardy Diagnostics
Decision Date2023-06-01
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HardyDisk AST Rezafungin 5µg (RZF5) is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2023-06-01 under 510(k) number K230827. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HardyDisk AST Rezafungin 5µg (RZF5)?

HardyDisk AST Rezafungin 5µg (RZF5) is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Hardy Diagnostics. The 510(k) number is K230827.

When did HardyDisk AST Rezafungin 5µg (RZF5) receive FDA 510(k) clearance?

HardyDisk AST Rezafungin 5µg (RZF5) received FDA 510(k) clearance on 2023-06-01, under 510(k) number K230827.

Who is the listed applicant for HardyDisk AST Rezafungin 5µg (RZF5)?

The FDA 510(k) record lists Hardy Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HardyDisk AST Rezafungin 5µg (RZF5)?

The FDA product code for HardyDisk AST Rezafungin 5µg (RZF5) is JTN.

Other records listing Hardy Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260842HardyDisk AST Gepotidacin 10µg (GEP10)K253105HardyDisk AST Cefiderocol 30µg (FDC30)K250956HardyDisk AST Gepotidacin 10µg (GEP10)K250454HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)K233534Viral Transport MediumK241060HardyDisk AST Cefiderocol 30µg (FDC30)

View all 22 devices →

Related Devices (Code: JTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60Thermo Fisher Scientific (Oxoid Ltd.)K261853Gepotidacin GEP 10 µgLiofilchem, Inc.K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy DiagnosticsK251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10Thermo Fisher Scientific (Oxoid Ltd.)K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy DiagnosticsK251879Sulopenem SPM 2 µgLiofilchem

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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