Cleared Traditional

SENSITITRE YEASTONE SUSCEPTIBILITY PLATES

K090968 · Trek Diagnostic Systems, Inc. · Microbiology

Jun 2009

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K090968 is an FDA 510(k) clearance for the SENSITITRE YEASTONE SUSCEPTIBILITY PLATES, a Susceptibility Test Plate, Antifungal (Class II — Special Controls, product code NGZ), submitted by Trek Diagnostic Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on June 4, 2009, 59 days after receiving the submission on April 6, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K090968 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2009
Decision Date	June 04, 2009
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

Product Code	NGZ — Susceptibility Test Plate, Antifungal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1640
Definition	The Device Is An In Vitro Diagnostic Device Intended For Use In Determining Quantitative Susceptibility Of Candida Species To Various Antifungal Agents Diluted In Varying Concentration In A Microtiter Plate Format.