ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545

Calibrator, Secondary

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Estradiol Calibrators On The Access Immunoassay Systems, Model 33545.

Pre-market Notification Details

Device IDK080166
510k NumberK080166
Device Name:ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
ClassificationCalibrator, Secondary
Applicant BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
ContactJeffrey L Koll
CorrespondentJeffrey L Koll
BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-23
Decision Date2008-03-19
Summary:summary

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