HEMOCUE HBA1C 501


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K121366
Device Name HEMOCUE HBA1C 501
Applicant
INFOPIA CO., LTD
55 northern blvd.
suite 200
great neck, 
NY 
11021

Applicant Contact maria f griffin
Correspondent
INFOPIA CO., LTD
55 northern blvd.
suite 200
great neck, 
NY 
11021

Correspodent Contact maria f griffin
Regulation Number 864.7470
Classification Product Code
LCP  
Date Received 05/07/2012
Decision Date 09/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No