FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K110641
FOIA Releasable 510(k) K110641
Device Name FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL
Applicant
FUJIREBIO DIAGNOSTICS, INC
940 crossroads blvd.
seguin, 
TX 
78155

Applicant Contact john gormley
Correspondent
FUJIREBIO DIAGNOSTICS, INC
940 crossroads blvd.
seguin, 
TX 
78155

Correspodent Contact john gormley
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 03/04/2011
Decision Date 05/27/2011
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