SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...

Manual Antimicrobial Susceptibility Test 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 (r) Hp Mic Susceptibility Plate With Cefaroline (0.004-8ug/ml) And The Sensititre (r) 18-24 Hour Mic Susce....

Pre-market Notification Details

Device IDK111429
510k NumberK111429
Device Name:SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...
ClassificationManual Antimicrobial Susceptibility Test 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 CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-23
Decision Date2011-08-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00848838091551 K111429 000
00848838091346 K111429 000
00848838018923 K111429 000
00848838018855 K111429 000
00848838018831 K111429 000

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