QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075


Device Classification Name

enzyme immunoassay, valproic acid

510(k) Number K030405
Device Name QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075
Applicant
SERADYN
7998 georgetown rd.
suite 1000
indianapolis, 
IN 
46268

Applicant Contact les padilla
Correspondent
SERADYN
7998 georgetown rd.
suite 1000
indianapolis, 
IN 
46268

Correspodent Contact les padilla
Regulation Number 862.3645
Classification Product Code
LEG  
Subsequent Product Code
JIS  
Date Received 02/06/2003
Decision Date 04/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No