SENSITITRE OPTIREAD

Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

TREK DIAGNOSTIC SYSTEMS, LTD.

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

Pre-market Notification Details

Device IDK110583
510k NumberK110583
Device Name:SENSITITRE OPTIREAD
ClassificationInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Applicant TREK DIAGNOSTIC SYSTEMS, LTD. 982 KEYNOTE CIRCLE SUITE 6 Cleveland,  OH  44131
ContactCynthia C Knapp
CorrespondentCynthia C Knapp
TREK DIAGNOSTIC SYSTEMS, LTD. 982 KEYNOTE CIRCLE SUITE 6 Cleveland,  OH  44131
Product CodeLRG  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-01
Decision Date2011-09-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00848838074530 K110583 000
05032384474530 K110583 000

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