ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K112029
Device Name ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05
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 862.1150
Classification Product Code
JIX  
Subsequent Product Code
JJY  
Date Received 07/15/2011
Decision Date 08/30/2011
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