AFINION ACR AND ACR CONTROL


Device Classification Name

enzymatic method, creatinine

510(k) Number K072409
Device Name AFINION ACR AND ACR CONTROL
Applicant
AXIS-SHIELD POC AS
marstrandgata 6
po box 6863
rodelokka, oslo, 

NO

n-0504

Applicant Contact jorunn grevie lolland
Correspondent
AXIS-SHIELD POC AS
marstrandgata 6
po box 6863
rodelokka, oslo, 

NO

n-0504

Correspodent Contact jorunn grevie lolland
Regulation Number 862.1225
Classification Product Code
JFY  
Subsequent Product Codes
JIR   JJY  
Date Received 08/27/2007
Decision Date 02/12/2008
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