ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE


Device Classification Name

gas chromatography, methamphetamine

510(k) Number K022589
Device Name ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
Original Applicant
ACON LABORATORIES, INC.
4108 sorrento valley blvd.
san diego, 
CA 
92121

Original Contact edward tung
Regulation Number 862.3610
Classification Product Code
LAF  
Date Received 08/05/2002
Decision Date 10/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No