DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM


Device Classification Name

alpha-2-macroglobulin, antigen, antiserum, control

510(k) Number K081249
Device Name DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
Applicant
DADE BEHRING, INC.
500 gbc dr, mailstop 514
newark, 
DE 
19714 -6101

Applicant Contact anna marie kathleen ennis
Correspondent
DADE BEHRING, INC.
500 gbc dr, mailstop 514
newark, 
DE 
19714 -6101

Correspodent Contact anna marie kathleen ennis
Regulation Number 866.5620
Classification Product Code
DEB  
Subsequent Product Codes
JIX   JJY  
Date Received 05/02/2008
Decision Date 07/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No