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FDA 510(k)

SENSITITRE YEASTONE SUSCEPTIBILITY PLATES

K-Number: K090968 · 2009-06-04

ApplicantTrek Diagnostic Systems, Inc.
Decision Date2009-06-04
Product CodeNGZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE YEASTONE SUSCEPTIBILITY PLATES 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 2009-06-04 under 510(k) number K090968. 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?

SENSITITRE YEASTONE SUSCEPTIBILITY PLATES is a medical device that received FDA 510(k) clearance on 2009-06-04. The listed applicant is Trek Diagnostic Systems, Inc.. The 510(k) number is K090968.

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

SENSITITRE YEASTONE SUSCEPTIBILITY PLATES received FDA 510(k) clearance on 2009-06-04, under 510(k) number K090968.

Who is the listed applicant for SENSITITRE YEASTONE SUSCEPTIBILITY PLATES?

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?

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

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Other records listing Trek Diagnostic Systems, 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.

K093865SENSITITRE 18-24HR SUSCEPTIBILITY PLATESK083606SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATESK081063SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICSK081520SENSITITRE VIZIONK073653SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATEK073558SENSITITRE 18-24 SUSCEPTIBILITY PLATE

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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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