ASIMANAGER – AT


Device Classification Name

densitometer/scanner (integrating, reflectance, tlc, radiochromat.) clinica

510(k) Number K111356
Device Name ASIMANAGER – AT
Applicant
ARLINGTON SCIENTIFIC, INC.
1840 north technology dr.
springville, 
UT 
84663

Applicant Contact david binks
Correspondent
ARLINGTON SCIENTIFIC, INC.
1840 north technology dr.
springville, 
UT 
84663

Correspodent Contact david binks
Regulation Number 862.2400
Classification Product Code
JQT  
Date Received 05/16/2011
Decision Date 11/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No