Cleared Traditional

THE SENSITITRE AIM

K103456 · Trek Diagnostic Systems · Microbiology
Jun 2011
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K103456 is an FDA 510(k) clearance for the THE SENSITITRE AIM, a Reagent/device, Inoculum Calibration (Class II — Special Controls, product code LIE), submitted by Trek Diagnostic Systems (Cleveland, US). The FDA issued a Cleared decision on June 22, 2011, 210 days after receiving the submission on November 24, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K103456 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2010
Decision Date June 22, 2011
Days to Decision 210 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LIE — Reagent/device, Inoculum Calibration
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

Similar Devices — LIE Reagent/device, Inoculum Calibration

MicroScan Prompt Inoculation System-D
K221493 · Beckman Coulter, Inc. · Apr 2023
SENSITITRE AIM (TM)
K110331 · Trek Diagnostic Systems, Ltd. · Apr 2011
SENSI-CAL AMCO AEPA-1
K935566 · Radiometer America, Inc. · Mar 1994
TURBIDOMETRIC STANDARD
K911059 · Scientific Device Laboratory, Inc. · Jun 1991
DIFCO DIRECTOR INOCULATION SYSTEM
K890339 · Difco Laboratories, Inc. · Feb 1989
PROMPT INOCULATION SYSTEM
K820299 · 3M Company · Mar 1982