DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA


Device Classification Name

transferrin, antigen, antiserum, control

510(k) Number K081299
Device Name DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA
Applicant
Siemens Healthcare Diagnostics Inc.
500 gbc drive
ms 514
newark, 
DE 
19702

Applicant Contact radames riesgo
Correspondent
Siemens Healthcare Diagnostics Inc.
500 gbc drive
ms 514
newark, 
DE 
19702

Correspodent Contact radames riesgo
Regulation Number 866.5880
Classification Product Code
DDG  
Subsequent Product Codes
JIX   JJY  
Date Received 05/08/2008
Decision Date 08/08/2008
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