KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT

Tyrosine Phosphatase (ia-2) Autoantibody Assay

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 Ia-2 Autoantibody Ria Assay Kit.

Pre-market Notification Details

Device IDK073590
510k NumberK073590
Device Name:KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT
ClassificationTyrosine Phosphatase (ia-2) Autoantibody Assay
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 CodeOIF  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-20
Decision Date2008-04-10

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