CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE


Device Classification Name

cyclosporine

510(k) Number K023065
Device Name CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
Original Applicant
DADE BEHRING, INC.
glasgow business community;
bldg. 500 p.o. box 6101
newark, 
DE 
19714 -6101

Original Contact lorraine piestrak
Regulation Number 862.1235
Classification Product Code
MKW  
Date Received 09/16/2002
Decision Date 10/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No