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FDA 510(k)

ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING

K-Number: K040560 · 2004-07-27

ApplicantAb Biodisk
Decision Date2004-07-27
Product CodeNGZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 2004-07-27 under 510(k) number K040560. The device is classified under product code NGZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING?

ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING is a medical device that received FDA 510(k) clearance on 2004-07-27. The listed applicant is Ab Biodisk. The 510(k) number is K040560.

When did ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING receive FDA 510(k) clearance?

ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING received FDA 510(k) clearance on 2004-07-27, under 510(k) number K040560.

Who is the listed applicant for ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING?

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

What is the FDA product code for ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING?

The FDA product code for ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING is NGZ.

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Other records listing Ab Biodisk 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.

K081325ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/MLK052366ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIAK042392DAPTOMYCINK042390ETEST FOR GEMIFLOXACINK021445ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAEK020748ETEST ERTAPENEM

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Related Devices (Code: NGZ)

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.

K243738The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mLThermo Fisher ScientificK232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)bioMerieux, Inc.K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)bioMerieux, Inc.K231433The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mLThermo Fisher ScientificK221198Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mLThermo Fisher ScientificK221899The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/mlThermo Fisher Scientific

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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