DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE


Device Classification Name

colorimetric method, lipoproteins

510(k) Number K081300
Device Name DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
ms 514, po box 6101
newark, 
DE 
19714 -6101

Applicant Contact pamela a jurga
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
ms 514, po box 6101
newark, 
DE 
19714 -6101

Correspodent Contact pamela a jurga
Regulation Number 862.1475
Classification Product Code
JHM  
Date Received 05/08/2008
Decision Date 07/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No