DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210


Device Classification Name

calibrator, secondary

510(k) Number K072717
Device Name DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
Applicant
DADE BEHRING, INC.
glasgow business community;
p.o. box 6101; mail box 514
newark, 
DE 
19714 -6101

Applicant Contact helen m lee
Correspondent
DADE BEHRING, INC.
glasgow business community;
p.o. box 6101; mail box 514
newark, 
DE 
19714 -6101

Correspodent Contact helen m lee
Regulation Number 862.1150
Classification Product Code
JIT  
Date Received 09/25/2007
Decision Date 12/12/2007
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