FDA 510(k)

SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS

K-Number: K081063 · 2009-03-06

Decision Date2009-03-06

Product CodeNGZ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS is the device name listed in this FDA 510(k) record. The listed applicant is Trek Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 2009-03-06 under 510(k) number K081063. 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 SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS?

SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS is a medical device that received FDA 510(k) clearance on 2009-03-06. The listed applicant is Trek Diagnostic Systems, Inc.. The 510(k) number is K081063.

When did SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS receive FDA 510(k) clearance?

SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS received FDA 510(k) clearance on 2009-03-06, under 510(k) number K081063.

Who is the listed applicant for SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS?

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

What is the FDA product code for SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS?

The FDA product code for SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS is NGZ.

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Other records listing Trek Diagnostic Systems, Inc. as applicant

K093865SENSITITRE 18-24HR SUSCEPTIBILITY PLATES K090968SENSITITRE YEASTONE SUSCEPTIBILITY PLATES K083606SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES K081520SENSITITRE VIZION K073653SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE K073558SENSITITRE 18-24 SUSCEPTIBILITY PLATE

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Related Devices (Code: NGZ)

K243738The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mLThermo Fisher Scientific K232967VITEK 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 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.