MEDTOXSCAN


Device Classification Name

enzyme immunoassay, amphetamine

510(k) Number K080635
Device Name MEDTOXSCAN
Applicant
MEDTOX DIAGNOSTICS, INC.
1238 anthony rd.
burlington, 
NC 
27215

Applicant Contact phillip hartzog
Correspondent
MEDTOX DIAGNOSTICS, INC.
1238 anthony rd.
burlington, 
NC 
27215

Correspodent Contact phillip hartzog
Regulation Number 862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
JJQ   JXM   LCM   LDJ  
Date Received 03/06/2008
Decision Date 02/13/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls