FDA 510(k)

VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)

K-Number: K151923 · 2016-03-25

Decision Date2016-03-25

Product CodeNGZ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) is a medical device manufactured by bioMerieux, Inc.. It received FDA 510(k) clearance on 2016-03-25 under approval number K151923. 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-Yeast Micafungin (0.06-8 mcg/mL)?

VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) is a medical device that received FDA 510(k) clearance on 2016-03-25. It is manufactured by bioMerieux, Inc.. The 510(k) number is K151923.

When was VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) approved by the FDA?

VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) received FDA 510(k) clearance on 2016-03-25, under approval number K151923.

What company makes VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)?

VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) is manufactured by bioMerieux, Inc..

What is the FDA product code for VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)?

The FDA product code for VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) is NGZ.

Other Devices by bioMerieux, Inc.

K162076chromID MRSA K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) K160911VIDAS B.R.A.H.M.S. PCT (PCT) K152075VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) K151688chromID MRSA K151817VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL

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Related Devices (Code: NGZ)

K151817VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLbioMerieux, Inc. K181368VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)bioMerieux, Inc. K211539Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mLThermo Fisher Scientific K231433The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mLThermo Fisher Scientific K221198Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mLThermo Fisher Scientific K221899The 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.