ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II


Device Classification Name

diazo colorimetry, bilirubin

510(k) Number K110780
Device Name ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II
Applicant
ELITECH GROUP
21720 23rd dr s.e., suite 150
bothell, 
WA 
98021

Applicant Contact debra k hutson
Correspondent
ELITECH GROUP
21720 23rd dr s.e., suite 150
bothell, 
WA 
98021

Correspodent Contact debra k hutson
Regulation Number 862.1110
Classification Product Code
CIG  
Subsequent Product Codes
JIX   JJY  
Date Received 03/21/2011
Decision Date 10/07/2011
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