KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT


Device Classification Name

system, test, thyroid autoantibody

510(k) Number K080159
Device Name KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA 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 866.5870
Classification Product Code
JZO  
Date Received 01/23/2008
Decision Date 05/22/2008
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