DIMENSION VISTA DIGITOXIN CALIBRATOR – DGTX CAL


Device Classification Name

calibrator, secondary

510(k) Number K103360
Device Name DIMENSION VISTA DIGITOXIN CALIBRATOR – DGTX CAL
Applicant
SIEMENS CORP.
500 gbc drive mailstop 514
p.o. box 6101
newark, 
DE 
19714

Applicant Contact rose t marinelli
Correspondent
SIEMENS CORP.
500 gbc drive mailstop 514
p.o. box 6101
newark, 
DE 
19714

Correspodent Contact rose t marinelli
Regulation Number 862.1150
Classification Product Code
JIT  
Date Received 11/16/2010
Decision Date 12/17/2010
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