A/C ENZYMATIC VITAMIN B6 ASSAY


Device Classification Name

radioassay, vitamin b12

510(k) Number K111260
Device Name A/C ENZYMATIC VITAMIN B6 ASSAY
Applicant
ANTICANCER INC
7917 ostrow st.
san diego, 
CA 
92111

Applicant Contact qinghong han
Correspondent
ANTICANCER INC
7917 ostrow st.
san diego, 
CA 
92111

Correspodent Contact qinghong han
Regulation Number 862.1810
Classification Product Code
CDD  
Date Received 05/05/2011
Decision Date 07/26/2012
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