Elecsys CA 15-3 II

System, Test, Immunological, Antigen, Tumor

Roche Diagnostics

The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Ca 15-3 Ii.

Pre-market Notification Details

Device IDK181492
510k NumberK181492
Device Name:Elecsys CA 15-3 II
ClassificationSystem, Test, Immunological, Antigen, Tumor
Applicant Roche Diagnostics 9115 Hague Road, P.O. Box 50416 Indianapolis,  IN  46250
ContactAdennis Cora
CorrespondentAdennis Cora
Roche Diagnostics 9115 Hague Road, P.O. Box 50416 Indianapolis,  IN  46250
Product CodeMOI  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-06
Decision Date2018-06-22
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.