Elecsys AFP

Kit, Test,alpha-fetoprotein For Testicular Cancer

Roche Diagnostics

The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Afp.

Pre-market Notification Details

Device IDK220176
510k NumberK220176
Device Name:Elecsys AFP
ClassificationKit, Test,alpha-fetoprotein For Testicular Cancer
Applicant Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
ContactJamie Ferguson
CorrespondentJamie Ferguson
Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
Product CodeLOJ  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-21
Decision Date2022-09-15

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