ADVANTAGE MARIJUANA (THC) HOME DRUG TEST


Device Classification Name

enzyme immunoassay, cannabinoids

510(k) Number K010921
Device Name ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
Original Applicant
ADVANTAGE DIAGNOSTICS CORP.
1201 douglas ave.
redwood city, 
CA 
94063

Original Contact janis freestone
Regulation Number 862.3870
Classification Product Code
LDJ  
Date Received 03/27/2001
Decision Date 06/25/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No