KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT


Device Classification Name

tyrosine phosphatase (ia-2) autoantibody assay

510(k) Number K073590
Device Name KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT
Applicant
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
12554 west bridger st.
suite 108
boise, 
ID 
83713

Applicant Contact heather viele
Correspondent
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
12554 west bridger st.
suite 108
boise, 
ID 
83713

Correspodent Contact heather viele
Regulation Number 866.5660
Classification Product Code
OIF  
Date Received 12/20/2007
Decision Date 04/10/2008
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