ENZYME II CALIBRATOR


Device Classification Name

calibrator, secondary

510(k) Number K103836
Device Name ENZYME II CALIBRATOR
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC
500 gbc drive
p.o. box 6101
newark, 
DE 
19714 -6101

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

Correspodent Contact anna marie kath ennis
Regulation Number 862.1150
Classification Product Code
JIT  
Date Received 12/30/2010
Decision Date 02/16/2011
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