ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K111996
Device Name ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
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 862.1660
Classification Product Code
JJY  
Date Received 07/13/2011
Decision Date 09/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No