QMS LIDOCAINE

Enzyme Immunoassay, Lidocaine

THERMO FISHER SCIENTIFIC INC.

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

Pre-market Notification Details

Device IDK090282
510k NumberK090282
Device Name:QMS LIDOCAINE
ClassificationEnzyme Immunoassay, Lidocaine
Applicant THERMO FISHER SCIENTIFIC INC. 7998 GEORGETOWN ROAD SUITE 1000 Indianapolis,  IN  46268 -9046
ContactJack Rogers
CorrespondentJack Rogers
THERMO FISHER SCIENTIFIC INC. 7998 GEORGETOWN ROAD SUITE 1000 Indianapolis,  IN  46268 -9046
Product CodeKLR  
CFR Regulation Number862.3555 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-02-05
Decision Date2009-05-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883006072 K090282 000

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