510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K991810Substantially Equivalent

Modification to Sensititre Yeastone Mic Susceptibility Test

Trek Diagnostic Systems, Ltd., Westlake OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991810 is the FDA 510(k) clearance record for MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST, a class II device, cleared for Trek Diagnostic Systems, Inc. on under FDA product code NGZ (Susceptibility Test Plate, Antifungal). FDA's definition for product code NGZ reads: "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". FDA records list 68 510(k) clearances for Trek Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K991810.

Clearance record

Decision date
Received
(866 days to decision)
Product code
NGZ Susceptibility Test Plate, Antifungal
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Trek Diagnostic Systems, Inc. 29299 Clemens Rd. Suite 1-K, Westlake OH
510(k) summary
Statement
Third party review
No

Clearances, product code NGZ

Trailing 12 months

FDA records hold no clearances under product code NGZ in the trailing twelve months.

FDA records show no clearances under product code NGZ in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NGZ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260