Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

ROCHE DIAGNOSTICS

The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Toxo Igm, Elecsys Toxo Igm Precicontrol.

Pre-market Notification Details

Device IDK162678
510k NumberK162678
Device Name:Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
ClassificationEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant ROCHE DIAGNOSTICS 9115 HAGUE RD. Indianapolis,  IN  46250
ContactKelli Turner
CorrespondentKelli Turner
ROCHE DIAGNOSTICS 9115 HAGUE RD. Indianapolis,  IN  46250
Product CodeLGD  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-26
Decision Date2017-06-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613336218464 K162678 000

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