KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT


Device Classification Name

autoantibodies, acetylcholine receptor, acetylcholine blocking and non-blocking

510(k) Number K080523
Device Name KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) 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
NST  
Date Received 02/26/2008
Decision Date 06/17/2008
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