VERDICT -II OPIATES 2000


Device Classification Name

enzyme immunoassay, opiates

510(k) Number K992111
Device Name VERDICT -II OPIATES 2000
Applicant
MEDTOX DIAGNOSTICS, INC.
1238 anthony rd.
burlington, 
NC 
27215

Correspondent
MEDTOX DIAGNOSTICS, INC.
1238 anthony rd.
burlington, 
NC 
27215

Regulation Number 862.3650
Classification Product Code
DJG  
Date Received 06/22/1999
Decision Date 12/16/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No