ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER

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 Analyzer.

Pre-market Notification Details

Device IDK002905
510k NumberK002905
Device Name:ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
ClassificationSystem, Test, Thyroglobulin
Applicant BECKMAN COULTER, INC. 7330 CARROLL RD. P.O. BOX 269006 San Diego,  CA  92196
ContactMara Caler
CorrespondentMara Caler
BECKMAN COULTER, INC. 7330 CARROLL RD. P.O. BOX 269006 San Diego,  CA  92196
Product CodeMSW  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-18
Decision Date2000-10-19

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