ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS


Device Classification Name

radioassay, vitamin b12

510(k) Number K110579
Device Name ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
Applicant
ABBOTT LABORATORIES
100 abbott park road
dept 9v6, ap5n-2
abbott park, 
IL 
60064

Applicant Contact darla abano
Correspondent
ABBOTT LABORATORIES
100 abbott park road
dept 9v6, ap5n-2
abbott park, 
IL 
60064

Correspodent Contact darla abano
Regulation Number 862.1810
Classification Product Code
CDD  
Subsequent Product Codes
JIT   JJX  
Date Received 03/01/2011
Decision Date 10/06/2011
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