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FDA 510(k)

HARDYDISK GENTAMICIN, 10MCG

K-Number: K994091 · 2000-02-11

ApplicantHardy Diagnostics
Decision Date2000-02-11
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HARDYDISK GENTAMICIN, 10MCG is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2000-02-11 under 510(k) number K994091. 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 GENTAMICIN, 10MCG?

HARDYDISK GENTAMICIN, 10MCG is a medical device that received FDA 510(k) clearance on 2000-02-11. The listed applicant is Hardy Diagnostics. The 510(k) number is K994091.

When did HARDYDISK GENTAMICIN, 10MCG receive FDA 510(k) clearance?

HARDYDISK GENTAMICIN, 10MCG received FDA 510(k) clearance on 2000-02-11, under 510(k) number K994091.

Who is the listed applicant for HARDYDISK GENTAMICIN, 10MCG?

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 GENTAMICIN, 10MCG?

The FDA product code for HARDYDISK GENTAMICIN, 10MCG is JTN.

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Other records listing Hardy Diagnostics as applicant

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K262113HardyDisk AST Tebipenem 10µg (TBP10)K260842HardyDisk AST Gepotidacin 10µg (GEP10)K253105HardyDisk AST Cefiderocol 30µg (FDC30)K250956HardyDisk AST Gepotidacin 10µg (GEP10)K250454HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)K233534Viral Transport Medium

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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.

K262113HardyDisk AST Tebipenem 10µg (TBP10)Hardy DiagnosticsK261781Thermo 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 Diagnostics

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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