KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT

System, Test, Thyroid Autoantibody

KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.

The following data is part of a premarket notification filed by Kronus Market Development Associates, Inc. with the FDA for Kronus Tsh Receptor Autoantibody (trab) Elisa Assay Kit.

Pre-market Notification Details

Device IDK080159
510k NumberK080159
Device Name:KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT
ClassificationSystem, Test, Thyroid Autoantibody
Applicant KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 12554 WEST BRIDGER ST. SUITE 108 Boise,  ID  83713
ContactHeather Viele
CorrespondentHeather Viele
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 12554 WEST BRIDGER ST. SUITE 108 Boise,  ID  83713
Product CodeJZO  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-23
Decision Date2008-05-22

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