KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT

Autoantibodies, Glutamic Acid Decarboxylase (gad)

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 Gad Autoantibody Elisa Assay Kit.

Pre-market Notification Details

Device IDK072135
510k NumberK072135
Device Name:KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT
ClassificationAutoantibodies, Glutamic Acid Decarboxylase (gad)
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 CodeNWG  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-02
Decision Date2007-11-07

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