VERDICT -II BAR; VERDICT -II BZO


Device Classification Name

enzyme immunoassay, barbiturate

510(k) Number K010959
Device Name VERDICT -II BAR; VERDICT -II BZO
Original Applicant
MEDTOX DIAGNOSTICS, INC.
1238 anthony rd.
burlington, 
NC 
27215

Original Contact michael turanchik
Regulation Number 862.3150
Classification Product Code
DIS  
Subsequent Product Code
JXM  
Date Received 03/30/2001
Decision Date 04/13/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Special
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized