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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Cannabinoids
510(k) Number K010921
Device Name ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
Applicant
ADVANTAGE DIAGNOSTICS CORP.
1201 DOUGLAS AVE.
REDWOOD CITY,  CA  94063
Applicant Contact JANIS FREESTONE
Correspondent
ADVANTAGE DIAGNOSTICS CORP.
1201 DOUGLAS AVE.
REDWOOD CITY,  CA  94063
Correspondent Contact JANIS FREESTONE
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received03/27/2001
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
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