DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K072435
Device Name DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
Applicant
DADE BEHRING, INC.
p.o. box 6101
newark, 
DE 
19714

Applicant Contact kathleen ennis
Correspondent
DADE BEHRING, INC.
p.o. box 6101
newark, 
DE 
19714

Correspodent Contact kathleen ennis
Regulation Number 862.1150
Classification Product Code
JIX  
Subsequent Product Code
JJY  
Date Received 08/30/2007
Decision Date 10/17/2007
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