DIMENSION VISA ENZ 2 CAL


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K103612
Device Name DIMENSION VISA ENZ 2 CAL
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC
500 gbc drive
p.o. box 6101
newark, 
DE 
19714 -6101

Applicant Contact anna marie k ennis
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS INC
500 gbc drive
p.o. box 6101
newark, 
DE 
19714 -6101

Correspodent Contact anna marie k ennis
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 12/09/2010
Decision Date 01/25/2011
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