KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT

Insulin Autoantibody Kit

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 Insulin Autoantibody (iaa) Assay Kit.

Pre-market Notification Details

Device IDK070183
510k NumberK070183
Device Name:KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT
ClassificationInsulin Autoantibody Kit
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 CodeOCN  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-19
Decision Date2007-07-13

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