DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST


Device Classification Name

method, nephelometric, immunoglobulins (g, a, m)

510(k) Number K081161
Device Name DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST
Applicant
DADE BEHRING, INC.
500 gbc dr, mailstop 514
newark, 
DE 
19714 -6101

Applicant Contact helen m lee
Correspondent
DADE BEHRING, INC.
500 gbc dr, mailstop 514
newark, 
DE 
19714 -6101

Correspodent Contact helen m lee
Regulation Number 866.5510
Classification Product Code
CFN  
Subsequent Product Codes
JIX   JJY  
Date Received 04/24/2008
Decision Date 07/28/2008
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