LIAISON 25 OH VITAMIN D TOTAL ASSAY


Device Classification Name

system, test, vitamin d

510(k) Number K112725
Device Name LIAISON 25 OH VITAMIN D TOTAL ASSAY
Applicant
DIASORIN, INC.
p.o. box 103
baldwin, 
MD 
21013

Applicant Contact judi smith
Correspondent
DIASORIN, INC.
p.o. box 103
baldwin, 
MD 
21013

Correspodent Contact judi smith
Regulation Number 862.1825
Classification Product Code
MRG  
Date Received 09/20/2011
Decision Date 01/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No