LIAISON XL ANALYZER MODEL 10050


Device Classification Name

hepatitis a test (antibody and igm antibody)

510(k) Number K103529
Device Name LIAISON XL ANALYZER MODEL 10050
Applicant
DIASORIN, INC.
195 northwestern ave.
p.o. box 285
stillwater, 
MN 
55082

Applicant Contact mari meyer
Correspondent
DIASORIN, INC.
195 northwestern ave.
p.o. box 285
stillwater, 
MN 
55082

Correspodent Contact mari meyer
Regulation Number 866.3310
Classification Product Code
LOL  
Subsequent Product Code
JJF  
Date Received 12/01/2010
Decision Date 01/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No