QMS LIDOCAINE CALIBRATORS, MODEL 0374678

Calibrators, Drug Specific

Thermo Fisher Scientific

The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Qms Lidocaine Calibrators, Model 0374678.

Pre-market Notification Details

Device IDK091617
510k NumberK091617
Device Name:QMS LIDOCAINE CALIBRATORS, MODEL 0374678
ClassificationCalibrators, Drug Specific
Applicant Thermo Fisher Scientific 7998 GEORGETOWN ROAD SUITE 1000 Indianapolis,  IN  46268
ContactJack Rogers
CorrespondentJack Rogers
Thermo Fisher Scientific 7998 GEORGETOWN ROAD SUITE 1000 Indianapolis,  IN  46268
Product CodeDLJ  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-03
Decision Date2009-07-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883000704 K091617 000

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