DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H


Device Classification Name

calibrator, secondary

510(k) Number K110169
Device Name DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 gbc drive
ms 514
newark, 
DE 
19702

Applicant Contact kathleen ann dray-lyons
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
500 gbc drive
ms 514
newark, 
DE 
19702

Correspodent Contact kathleen ann dray-lyons
Regulation Number 862.1150
Classification Product Code
JIT  
Subsequent Product Code
JJX  
Date Received 01/20/2011
Decision Date 04/07/2011
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