DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON


Device Classification Name

complement c1 inhibitor (inactivator), antigen, antiserum, control

510(k) Number K072965
Device Name DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON
Applicant
DADE BEHRING, INC.
p.o. box 6101
newark,, 
DE 
19714

Applicant Contact kathleen dray-lyons
Correspondent
DADE BEHRING, INC.
p.o. box 6101
newark,, 
DE 
19714

Correspodent Contact kathleen dray-lyons
Regulation Number 866.5250
Classification Product Code
DBA  
Subsequent Product Codes
JIT   JJX  
Date Received 10/22/2007
Decision Date 12/21/2007
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