DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR


Device Classification Name

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

510(k) Number K073561
Device Name DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
Applicant
DADE BEHRING, INC.
p.o box 6101, ms514
newark, 
DE 
19714 -6101

Applicant Contact helen m lee
Correspondent
DADE BEHRING, INC.
p.o box 6101, ms514
newark, 
DE 
19714 -6101

Correspodent Contact helen m lee
Regulation Number 866.5510
Classification Product Code
CFN  
Subsequent Product Codes
JIX   JJY  
Date Received 12/19/2007
Decision Date 02/26/2008
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