QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM


Device Classification Name

enzyme immunoassay, digoxin

510(k) Number K023058
Device Name QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
Original Applicant
SERADYN
7998 georgetown rd.
suite 1000
indianapolis, 
IN 
46268

Original Contact lisa brown
Regulation Number 862.3320
Classification Product Code
KXT  
Subsequent Product Code
DLJ  
Date Received 09/13/2002
Decision Date 10/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No