DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B


Device Classification Name

colorimetric method, lipoproteins

510(k) Number K073072
Device Name DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
Applicant
DADE BEHRING, INC.
glasgow business community;
bldg. 500 mail box 514
p.o. box 6101, newark, 
DE 
19714 -6101

Applicant Contact pamela a jurga
Correspondent
DADE BEHRING, INC.
glasgow business community;
bldg. 500 mail box 514
p.o. box 6101, newark, 
DE 
19714 -6101

Correspodent Contact pamela a jurga
Regulation Number 862.1475
Classification Product Code
JHM  
Date Received 10/31/2007
Decision Date 02/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No