Elecsys Vitamin B12 II Assay, Elecsys Vitamin B12 II CalSet

Radioassay, Vitamin B12

Roche Diagnostics

The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Vitamin B12 Ii Assay, Elecsys Vitamin B12 Ii Calset.

Pre-market Notification Details

Device IDK151786
510k NumberK151786
Device Name:Elecsys Vitamin B12 II Assay, Elecsys Vitamin B12 II CalSet
ClassificationRadioassay, Vitamin B12
Applicant Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
ContactKelli Turner
CorrespondentKelli Turner
Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
Product CodeCDD  
CFR Regulation Number862.1810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-01
Decision Date2015-09-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04015630940684 K151786 000
04015630939848 K151786 000

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