ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH


Device Classification Name

bromcresol green dye-binding, albumin

510(k) Number K110830
Device Name ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH
Applicant
ELITECHGROUP
21720 23rd dr se
suite 150
bothell, 
WA 
98021

Applicant Contact debra k hutson
Correspondent
ELITECHGROUP
21720 23rd dr se
suite 150
bothell, 
WA 
98021

Correspodent Contact debra k hutson
Regulation Number 862.1035
Classification Product Code
CIX  
Subsequent Product Codes
CJY   JIX   JJY  
Date Received 03/25/2011
Decision Date 06/21/2011
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

Recalls CDRH Recalls