Elecsys HCG STAT

System, Test, Human Chorionic Gonadotropin

ROCHE DIAGNOSTICS

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

Pre-market Notification Details

Device IDK203227
510k NumberK203227
Device Name:Elecsys HCG STAT
ClassificationSystem, Test, Human Chorionic Gonadotropin
Applicant ROCHE DIAGNOSTICS 9115 Hague Road PO Box 50416 Indianapolis,  IN  46250
ContactAdennis N. Cora
CorrespondentAdennis N. Cora
ROCHE DIAGNOSTICS 9115 Hague Road PO Box 50416 Indianapolis,  IN  46250
Product CodeDHA  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-02
Decision Date2021-08-18

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