LABONACHECK A1C


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K111128
Device Name LABONACHECK A1C
Applicant
CERAGEM INTERNATIONAL, INC.
3699 wilshire blvd.,suite 930
los angeles, 
CA 
90010

Applicant Contact raymond chung
Correspondent
CERAGEM INTERNATIONAL, INC.
3699 wilshire blvd.,suite 930
los angeles, 
CA 
90010

Correspodent Contact raymond chung
Regulation Number 864.7470
Classification Product Code
LCP  
Date Received 04/21/2011
Decision Date 09/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No