ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

System, Test, Thyroglobulin

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Thyroglobulin Reagents On The Access Immunoassay Systems.

Pre-market Notification Details

Device IDK031269
510k NumberK031269
Device Name:ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
ClassificationSystem, Test, Thyroglobulin
Applicant BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
ContactLynn Weist
CorrespondentLynn Weist
BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
Product CodeMSW  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-21
Decision Date2003-05-02
Summary:summary

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