FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS

Calibrator, Secondary

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Free T3 Calibrators On The Access Immunoassay Systems.

Pre-market Notification Details

Device IDK042651
510k NumberK042651
Device Name:FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
ClassificationCalibrator, Secondary
Applicant BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
ContactValynda Machen
CorrespondentValynda Machen
BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-28
Decision Date2004-10-05
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.