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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name voltage gated calcium channel (vgcc) antibody assay
510(k) Number K111956
Device Name KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
Applicant
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
170 S SENECA SPRINGS WAY
SUITE 105
STAR,  ID  83669
Applicant Contact HEATHER VIELE
Correspondent
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
170 S SENECA SPRINGS WAY
SUITE 105
STAR,  ID  83669
Correspondent Contact HEATHER VIELE
Regulation Number866.5660
Classification Product Code
PAF  
Date Received07/11/2011
Decision Date 05/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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