Elecsys Anti-HAV II

Hepatitis A Test (antibody And Igm Antibody)

Roche Diagnostics

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

Pre-market Notification Details

Device IDK190428
510k NumberK190428
Device Name:Elecsys Anti-HAV II
ClassificationHepatitis A Test (antibody And Igm Antibody)
Applicant Roche Diagnostics 9115 Hague Road, PO Box 50416 Indianapolis,  IN  46250
ContactJamie Ferguson
CorrespondentJamie Ferguson
Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
Product CodeLOL  
CFR Regulation Number866.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-22
Decision Date2019-08-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613336129746 K190428 000
07613336129722 K190428 000
07613336129715 K190428 000

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