Elecsys AMH

Anti-müllerian Hormone Test System

Roche Diagnostics

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

Pre-market Notification Details

Device IDK203757
510k NumberK203757
Device Name:Elecsys AMH
ClassificationAnti-müllerian Hormone Test System
Applicant Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
ContactEdie Eads
CorrespondentEdie Eads
Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
Product CodePQO  
CFR Regulation Number862.1092 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-23
Decision Date2022-06-10

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.