Access HsTnl

Immunoassay Method, Troponin Subunit

Beckman Coulter, Inc.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Hstnl.

Pre-market Notification Details

Device IDK172787
510k NumberK172787
Device Name:Access HsTnl
ClassificationImmunoassay Method, Troponin Subunit
Applicant Beckman Coulter, Inc. Immunodiagnostic Development Center 1000 Lake Hazeltine Drive Chaska,  MN  55318
ContactJennifer Lee Bennett
CorrespondentJennifer Bennett
Beckman Coulter, Inc. Immunodiagnostic Development Center 1000 Lake Hazeltine Drive Chaska,  MN  55318
Product CodeMMI  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-15
Decision Date2018-06-14
Summary:summary

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