KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT

Voltage Gated Calcium Channel (vgcc) Antibody 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 Voltage Gated Calcium Channel (vgcc) Antibody Ria Assay Kit.

Pre-market Notification Details

Device IDK111956
510k NumberK111956
Device Name:KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
ClassificationVoltage Gated Calcium Channel (vgcc) Antibody Assay
Applicant KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 170 S SENECA SPRINGS WAY SUITE 105 Star,  ID  83669
ContactHeather Viele
CorrespondentHeather Viele
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 170 S SENECA SPRINGS WAY SUITE 105 Star,  ID  83669
Product CodePAF  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-11
Decision Date2012-05-30

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