THE SENSITITRE AIM

Reagent/device, Inoculum Calibration

TREK DIAGNOSTIC SYSTEMS

The following data is part of a premarket notification filed by Trek Diagnostic Systems with the FDA for The Sensititre Aim.

Pre-market Notification Details

Device IDK103456
510k NumberK103456
Device Name:THE SENSITITRE AIM
ClassificationReagent/device, Inoculum Calibration
Applicant TREK DIAGNOSTIC SYSTEMS 982 KEYNOTE CIRCLE Cleveland,  OH  44131
ContactCynthia C Knapp
CorrespondentCynthia C Knapp
TREK DIAGNOSTIC SYSTEMS 982 KEYNOTE CIRCLE Cleveland,  OH  44131
Product CodeLIE  
Subsequent Product CodeJWY
Subsequent Product CodeLRG
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-24
Decision Date2011-06-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00848838097409 K103456 000
05032384497409 K103456 000

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