ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)


Device Classification Name

radioassay, vitamin b12

510(k) Number K112443
Device Name ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
the technology park
luna place
dundee,, 

GB

dd2 1xa

Applicant Contact claire i dora
Correspondent
AXIS-SHIELD DIAGNOSTICS, LTD.
the technology park
luna place
dundee,, 

GB

dd2 1xa

Correspodent Contact claire i dora
Regulation Number 862.1810
Classification Product Code
CDD  
Subsequent Product Codes
JIT   JJX  
Date Received 08/24/2011
Decision Date 12/19/2011
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