ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS


Device Classification Name

system, test, vitamin d

510(k) Number K110619
Device Name ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
Applicant
BIOKIT S.A.
can male, s/n
llissa d’amunt, barcelona, 

ES

08186

Applicant Contact joan guixer
Correspondent
BIOKIT S.A.
can male, s/n
llissa d’amunt, barcelona, 

ES

08186

Correspodent Contact joan guixer
Regulation Number 862.1825
Classification Product Code
MRG  
Subsequent Product Codes
JIT   JJX  
Date Received 03/03/2011
Decision Date 11/23/2011
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

Recalls CDRH Recalls