EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W


Device Classification Name

system, hemoglobin, automated

510(k) Number K110393
Device Name EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W
Applicant
EKF-DIAGNOSTIC GMBH
s65 w35739 piper road
eagle, 
WI 
53119

Applicant Contact stephen gorski
Correspondent
EKF-DIAGNOSTIC GMBH
s65 w35739 piper road
eagle, 
WI 
53119

Correspodent Contact stephen gorski
Regulation Number 864.5620
Classification Product Code
GKR  
Subsequent Product Code
KHG  
Date Received 02/11/2011
Decision Date 03/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No