510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110331Substantially Equivalent

Sensititre Aim (Tm)

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

K110331 is the FDA 510(k) clearance record for SENSITITRE AIM (TM), a class II device, cleared for Trek Diagnostic Systems, Ltd. on under FDA product code LIE (Reagent/Device, Inoculum Calibration). FDA records list 68 510(k) clearances for Trek Diagnostic Systems, Ltd., from to . As of , FDA records show no recalls naming K110331.

Clearance record

Decision date
Received
(83 days to decision)
Product code
LIE Reagent/Device, Inoculum Calibration
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Trek Diagnostic Systems, Ltd. 982 Keynote Cir., Suite 6, Cleveland OH
510(k) summary
Statement
Third party review
No

Clearances, product code LIE

Trailing 12 months

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

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