MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST

Susceptibility Test Plate, Antifungal

TREK DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Trek Diagnostic Systems, Inc. with the FDA for Modification To Sensititre Yeastone Mic Susceptibility Test.

Pre-market Notification Details

• Device ID: K991810
• 510k Number: K991810
• Device Name: MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST
• Classification: Susceptibility Test Plate, Antifungal
• Applicant: TREK DIAGNOSTIC SYSTEMS, INC. 29299 CLEMENS RD., SUITE 1-K Westlake, OH 44145
• Contact: Cynthia C Knapp
• Correspondent: Cynthia C Knapp; TREK DIAGNOSTIC SYSTEMS, INC. 29299 CLEMENS RD., SUITE 1-K Westlake, OH 44145
• Product Code: NGZ
• CFR Regulation Number: 866.1640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-05-27
• Decision Date: 2001-10-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05032384474561	K991810	000
05032384503513	K991810	000