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


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

Correspodent Contact heather viele
Regulation Number 866.5660
Classification Product Code
PAF  
Date Received 07/11/2011
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