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FDA 510(k)

VITEK 2 AST-YS FLUCONAZOLE

K-Number: K061945 · 2006-09-19

ApplicantbioMerieux, Inc.
Decision Date2006-09-19
Product CodeNGZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VITEK 2 AST-YS FLUCONAZOLE is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2006-09-19 under 510(k) number K061945. 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 VITEK 2 AST-YS FLUCONAZOLE?

VITEK 2 AST-YS FLUCONAZOLE is a medical device that received FDA 510(k) clearance on 2006-09-19. The listed applicant is bioMerieux, Inc.. The 510(k) number is K061945.

When did VITEK 2 AST-YS FLUCONAZOLE receive FDA 510(k) clearance?

VITEK 2 AST-YS FLUCONAZOLE received FDA 510(k) clearance on 2006-09-19, under 510(k) number K061945.

Who is the listed applicant for VITEK 2 AST-YS FLUCONAZOLE?

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

What is the FDA product code for VITEK 2 AST-YS FLUCONAZOLE?

The FDA product code for VITEK 2 AST-YS FLUCONAZOLE is NGZ.

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Other records listing bioMerieux, Inc. 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.

K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemK260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistanceK251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)K234012VITEK COMPACT PROK232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

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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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