AFINION ANALYZER


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K110056
Device Name AFINION ANALYZER
Applicant
AXIS-SHIELD POC AS
p.o. box 6863
rodelokka
oslo, 

NO

n-0504

Applicant Contact kari skinnemoen
Correspondent
AXIS-SHIELD POC AS
p.o. box 6863
rodelokka
oslo, 

NO

n-0504

Correspodent Contact kari skinnemoen
Regulation Number 864.7470
Classification Product Code
LCP  
Subsequent Product Codes
DCK   JFY   JIR   JJX   JJY  
JQT  
Date Received 01/10/2011
Decision Date 02/15/2011
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