ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS


Device Classification Name

enzymatic, carbon-dioxide

510(k) Number K111960
Device Name ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS
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 862.1160
Classification Product Code
KHS  
Subsequent Product Code
JIX  
Date Received 07/11/2011
Decision Date 11/18/2011
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